Systems and methods for manufacturing a stent frame

ABSTRACT

A prosthetic heart valve can include a support structure, an actuator member, and a plurality of leaflets. The support structure can have a plurality of struts and a plurality of rivets. The struts can have openings formed therein. The rivets can have first portions and second portions. The first portions can extend through the openings of the struts, and the second portions are larger than the first portion and the openings of the struts. The struts are pivotable about the rivets to radially expand and compress the support structure. The actuator member can be coupled to the struts of the support structure and configured to selectively actuate expansion and compression of the support structure. The leaflets can be coupled to the support structure and configured to allow unidirectional blood flow through the prosthetic heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/538,705, filed Nov. 11, 2014, now U.S. Pat. No. 9,700,442, whichclaims the benefit of U.S. Provisional Application No. 61/902,726 filedNov. 11, 2013. Both of these applications are incorporated by referenceherein.

BACKGROUND

Endoluminal stents can be implanted in a vessel or tract of a patient tohelp maintain an open lumen. The stents can also be used as a frame tosupport a prosthetic device or to deliver a therapeutic agent. Stentscan be implanted by either an open operative procedure or a closedoperative procedure. When an option exists, the less invasive closedprocedure is generally preferred because the stent can be guided througha body lumen, such as the femoral artery, to its desired location.

Closed procedures typically use one of two techniques. One closedprocedure employs balloon catheterization where an expandable stentencloses an inflatable balloon. In this procedure, the stent isimplanted by inflating the balloon, which causes the stent to expand.The actual positioning of the stent cannot be determined until after theballoon is deflated and, if there is a misplacement of the stent, theprocess cannot be reversed to reposition the stent.

The other closed procedure employs a compressed stent enclosed by aremovable sheath. In this procedure, a stent made from a shape memoryalloy, such as Nitinol, is held in a compressed state by a sheath. Thestent is implanted by withdrawing the sheath, causing the stent toexpand to its nominal shape. Again, if there is a misplacement of thestent, the process cannot be reversed to reposition the stent.

Positioning errors are particularly dangerous when the stent is used tosupport a cardiac valve. Serious complications and patient deaths haveoccurred due to malpositioning of the valve at the implant site in thebody, using the available stent-mounted valves. Malpositioning of thevalve has resulted in massive paravalvular leakage, device migration,and coronary artery obstruction. The majority of these complicationswere unavoidable, but detected at the time of the procedure. However,due to inability to reposition or retrieve the device, these problemswere impossible to reverse or mitigate during the procedure.

SUMMARY

An endoluminal support structure or stent in accordance with certainembodiments of the invention solves certain deficiencies found in theprior art. In particular, the support structure can be repositionedwithin the body lumen or retrieved from the lumen.

A particular embodiment of the invention includes a support apparatusimplantable within a biological lumen. The support apparatus can includea plurality of elongated strut members interlinked by a plurality ofrotatable joints, wherein the rotatable joints can cooperate with thestent members to adjustably define a shaped structure between acompressed orientation and an expanded orientation.

More particularly, the shaped structure can be one of a cylindrical, aconical, or an hourglass shape. A rotatable joint can form a scissormechanism with a first strut member and a second strut member.Furthermore, the strut members can be arranged as a series of linkedscissor mechanisms. The apparatus can further include an actuator tourge the rotatable joints within a range of motion.

The apparatus can also include a prosthetic valve coupled to the shapedstructure.

Another particular embodiment of the invention can include a medicalstent implantable within a biological lumen. The medical stent caninclude a plurality of elongated strut members, including a first strutmember and a second strut member, and an articulated joint connectingthe first strut member and the second strut member.

In particular, the articulated joint can form a scissor mechanism withthe first strut member and the second strut member. The articulatedjoint can bisect the first strut member and the second strut member. Thearticulated joint can interconnect a first end of the first strut memberwith a first end of the second strut member.

The plurality of strut members can be arranged as a series of linkedscissor mechanisms. The strut members can also be non-linear. The strutmembers can be arranged to form one of a cylindrical, a conical, or anhourglass shape.

The stent can further include an adjustment mechanism to exert a forceto urge the strut members about the articulated joint within a range ofmotion.

The stent can include a prosthetic valve coupled to the strut members.

Specific embodiments of the invention can include prosthetic valves thatare rotatable or conventional.

A rotatable prosthetic valve can include a first structural membercoupled to the strut members, a second structural member rotatablerelative to the first structural member, and a plurality of pliablevalve members connecting the first structural member with the secondstructural member such that rotation of the second structural memberrelative to the first structural member can urge the valve membersbetween an open and a closed state. In particular, the rotation of thesecond structural member can be responsive to the natural flow of abiological fluid.

A conventional prosthetic valve can include a plurality of pliable valveleaflets having commissures at the intersection of two strut members.The prosthetic valve can further include a skirt material coupled to thestrut members.

These structures can also be interconnected in various combinations.

A particular advantage of a support structure in accordance withembodiments of the invention is that it enables a prosthetic valve to bereadily retrieved and repositioned in the body. If following deployment,the valve is malpositioned or deemed dysfunctional, the supportstructure allows the valve to be readily repositioned and re-deployed ata new implant site, or removed from the body entirely. This feature ofthe device can prevent serious complications and save lives by enablingthe repair of mal-positioned devices in the body.

Also described here are methods of fabricating an articulated supportstructure. In some variations, the method comprises placing a pluralityof pins through openings in an alignment plate, placing a plurality ofeyelets onto the plurality of pins, layering a plurality of strutmembers each having a plurality of orifices onto the plurality of pinsby placing the pins through the orifices, connecting the plurality ofstrut members into a chain having a first end and a second end byswaging the eyelets, and wrapping the chain into a tubular structure byconnecting the first and second ends of the chain. In some of thesevariations, the method further comprises placing a plurality of valveleaflets onto the plurality of pins, wherein at least one of theplurality of strut members is layered below each valve leaflet, and atleast one of the plurality of strut members is layered above each valveleaflet. In some of these variations, the method further comprisesbiasing the valve leaflets into a closed configuration after wrappingthe chain into a tubular structure, by rotating at least one of theplurality of strut members from a first position to a second position.In some of these variations, the method further comprises placing askirt material onto the plurality of pins, wherein at least one of theplurality of strut members is layered below the skirt material, and atleast one of the plurality of strut members is layered above the skirtmaterial. In some of these variations, the method further comprisesattaching an actuator to the articulated support structure, wherein theactuator is configured to reversibly and incrementally adjust thearticulated support structure between an expanded configuration and acompressed configuration. In some of these variations, the methodfurther comprises attaching the articulated support structure to asecond articulated support structure. In some of these variations, themethod further comprises attaching an actuator to the second articulatedsupport structure, wherein the actuator is configured to reversibly andincrementally adjust the articulated support structure and the secondarticulated support structure between an expanded configuration and acompressed configuration. In some variations, the method furthercomprises placing a skirt material onto the plurality of pins, whereinat least one of the plurality of strut members is layered below theskirt material, and at least one of the plurality of strut members islayered above the skirt material. In some of these variations, themethod further comprises attaching the articulated support structure toa second articulated support structure. In some of these variations, themethod further comprises attaching an actuator to the articulatedsupport structure, wherein the actuator is configured to reversibly andincrementally adjust the articulated support structure and the secondarticulated support structure between an expanded configuration and acompressed configuration. In other variations, the method may compriseplacing skirt material onto the plurality of pins prior to placement ofany strut members. The method may also comprise tucking the skirtmaterial in between at least two of the plurality of strut members. Thetucking may be performed without using any sutures attached to the skirtmaterial, and may comprise using one or more wrapping or folding pin topierce the skirt material and then pivoting the pin against one strut ofthe plurality of strut members to wrap the skirt material over the onestrut. The wrapping or folding pin may be inserted against an adjacentstrut to wrap the skirt material around the strut. The wrapping orfolding pin may then be further pushed or inserted temporarily under thestrut after wrapping the skirt material over the one strut. The skirtmaterial may be held against the strut by piercing the skirt material attwo different locations with the pin. A second strut is then attached tothe valve assembly and the wrapping or folding may then be removed fromthe skirt material.

In some variations, the method of fabricating an articulated supportstructure comprises interlinking a plurality of strut members into aflattened chain having a first end and a second end, wherein each of theplurality of strut members comprises a plurality of orifices, comprisingplacing a plurality of alignment guides through at least one orifice ofeach of the plurality of strut members, wherein each of the plurality ofalignment guides is placed through the orifices of at least two strutmembers, securing the at least two strut members together, removing theplurality of alignment guides from the orifice, and connecting the firstend of the flattened chain to the second end of the flattened chain toform a tubular structure. In some of these variations, the methodfurther comprises securing a valve comprising a plurality of valveleaflets to the support structure, wherein securing the valve to thesupport structure comprises sandwiching the valve leaflets between thestrut members. In some of these variations, the plurality of strutmembers comprises a plurality of coaptation strut members. In some ofthese variations, the method further comprises further comprisingrotating the coaptation struts from a first position to a secondposition to bias the valve toward a closed configuration. In somevariations, the method further comprises securing a skirt to the supportstructure, wherein securing the skirt to the support structure comprisessandwiching the skirt between the strut members. In some of thesevariations, the method further comprises interlinking a second pluralityof strut members into a second flattened chain having a first end and asecond end, wherein each of the second plurality of strut memberscomprises a plurality of orifices, comprising placing a second pluralityof alignment guides through at least one orifice of each of the secondplurality of strut members, wherein each of the second plurality ofalignment guides is placed through the orifices of at least two strutmembers of the second plurality of strut members, securing the at leasttwo strut members of the second plurality of strut members together,removing the second plurality of alignment guides from the orifice, andconnecting the first end of the second flattened chain to the second endof the second flattened chain to form a second tubular structure, andsecuring a skirt to the second tubular structure, wherein securing theskirt to the second tubular structure comprises sandwiching the skirtbetween the strut members.

Also described here are articulated support structures configured to beplaced in a lumen. In some variations, the articulated support structurecomprises a plurality of strut members connected by a plurality ofarticulated joints into a tubular shape, a plurality of valve leafletsforming a valve, wherein each of the plurality of valve leaflets issandwiched between at least two of the plurality of strut members, and askirt configured to help seal the valve in the lumen, wherein the skirtis sandwiched between at least two of the plurality of strut members. Insome of these variations, the articulated support structure isreversibly and incrementally adjustable between an expandedconfiguration and a compressed configuration. In some of thesevariations, the articulated support structure further comprises anactuator, wherein the actuator is configured to reversibly andincrementally adjust the articulated support structure between anexpanded configuration and a compressed configuration. In somevariations, the articulated support structure does not comprise anysutures. In some variations, the articulated support structure furthercomprises a plurality of coaptation struts, wherein the coaptationstruts are configured to bias the valve toward a closed configuration.

In another embodiment, an assembly system for an articulated structure,comprising a backing support, the backing support comprising a pluralityof backing support strut alignment openings, and a cover plate, thecover support comprising and a plurality of cover support strutalignment openings, wherein the plurality of backing support strutalignment openings are aligned with the plurality of cover support strutalignment openings. The backing support may further comprise indiciaalong the plurality of backing support strut alignment openingsindicating strut positions. The backing support may further comprise atleast one swaging alignment structure.

The assembly system may further comprise a plurality of alignment pinsconfigured to reside in the plurality of backing support strut alignmentopenings and the plurality of cover support strut alignment openings.The assembly system may further comprise a plurality of struts and aplurality of eyelets. The assembly may further comprise a plurality ofvalve leaflets. The assembly system may further comprise at least onesealing material. Each of the plurality of sealing material sheets maycomprise at least one attaching tab. The assembly further comprises aplurality of struts comprising a plurality of primary struts and aplurality of commissure struts. The backing support may further compriseat least one cover support retaining structure. The at least one coversupport retaining structure may comprise a clip. At least one of thebacking support and the cover support may comprise a support alignmentstructure configured to facilitate alignment of the backing support andthe cover support. The backing support may be a backing plate, and thecover support may be a cover plate. The backing support may furthercomprise at least one jig alignment structure. The assembly system mayfurther comprise a shim or protective insert. The protective insert maycomprise a plurality of alignment openings, and/or may comprise baseregions and commissure regions. The base regions may each comprise atriangular shape, and the commissure regions may comprise an elongateshape.

In another embodiment, a medical device is provided, comprising a firstplurality of separate struts in a first tubular scissor linkageconfiguration, wherein at least one strut of the first plurality ofseparate struts comprises an integrally formed U-shape or V-shape strut.Two or three struts of the first plurality of separate struts maycomprise once-piece or integrally formed U-shape or V-shape struts. Thefirst plurality of separate struts may further comprise a plurality ofinner struts and a plurality of outer struts configured in the scissorlinkage configuration. The integrally formed U-shape or V-shape strutmay be attached to one of the first plurality of inner struts and one ofthe first plurality of outer struts. The U-shape or V-shape strut maycomprise an apical opening. The U-shape or V-shape strut may comprise anapical extension the apical opening is located on the apical extension.The medical device may further comprise a sealing structure, the sealingstructure comprising at least one base region and at least one extensionregion, wherein the at least one extension region is coupled to the atleast one strut of the first plurality of separate struts comprising theintegrally formed U-shape or V-shape strut. The extension region maycomprise at least one tab configured to wrap around the at least onestrut of the first plurality of separate struts comprising theintegrally formed U-shape or V-shape strut. The at least one tab may besutured to the at least one strut of the first plurality of separatestruts comprising the integrally formed U-shape or V-shape strut. The atleast one base region comprises may be compressed between two struts ofthe first plurality of separate struts. The medical device may furthercomprise a second plurality of separate struts in a second tubularscissor linkage configuration, wherein the first plurality of separatestruts is located in a lumen of the second tubular scissor linkageconfiguration of the secondary plurality of separate struts. The medicaldevice may further comprise at least one valve leaflet attached to atleast one strut of the first plurality of separate struts comprises anintegrally formed U-shape or V-shape strut.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of theinvention will be apparent from the following more particulardescription of particular embodiments of the invention, as illustratedin the accompanying drawings in which like reference characters refer tothe same parts throughout the different views. The drawings are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention.

FIG. 1A is a perspective view of a particular endoluminal supportstructure. FIG. 1B is a perspective view of a four strut section of thestent of FIG. 1A. FIGS. 1C-1D are perspective views of the supportstructure of FIG. 1A. FIG. 1D is a perspective view of the supportstructure of FIG. 1A in a fully expanded state.

FIGS. 2A-2C illustrate perspective views of variations of a particularendoluminal support structure.

FIG. 3 is a perspective view of the arrangement of strut members in aconical-shaped support structure configuration.

FIG. 4 is a side perspective view of a particular endoluminal supportstructure.

FIG. 5 is a side perspective view of a particular endoluminal supportstructure with Dacron-sealed struts.

FIG. 6A is a perspective view of a particular endoluminal supportstructure. FIG. 6B is a perspective view of a six strut section of thestructure of FIG. 6A.

FIG. 7A is a perspective view of another embodiment of an endoluminalsupport structure. FIG. 7B is a perspective view of a variation of thestructure of FIG. 7A.

FIG. 8A is a perspective view of a linkage of the support structure ofFIG. 1A having a particular actuator. FIG. 8B is a perspective view of alinkage of the support structure of FIG. 1A having another particularactuator.

FIG. 9 is a perspective view of a particular support structure andcontrol catheter assembly usable with the actuator of FIGS. 8A and 8B.

FIG. 10 is a side perspective view of the support structure of FIG. 2Ahaving a particular actuator.

FIG. 11A shows a rotary instrument for controlling an actuator from alocation remote from the implant site. FIG. 11B shows the rotaryinstrument of FIG. 11A with an attached catheter, attached to theactuator and support structure of FIG. 10. FIGS. 11C-11D show the end ofthe catheter attached to the actuator and support structure of FIG. 20in expanded and compressed configurations, respectively.

FIG. 12 is a side view of a control catheter assembly.

FIG. 13 is a perspective view of a tissue valve mounted to the supportstructure of FIG. 1A.

FIG. 14 is a perspective view of a tissue valve mounted to the structureof FIG. 10A.

FIG. 15 is a schematic illustration of a valve leaflet.

FIG. 16A is a top perspective view of a particular alignment plate.

FIG. 16B-16W show steps in a method of fabrication.

FIG. 16X is a top perspective view of a particular base frame.

FIGS. 17A-17E illustrate configurations of the strut members used in themethod of fabrication shown in FIGS. 16B-16W. FIGS. 17F-17G illustrate aside cutaway view and a schematic side view, respectively, of an eyeletused in the method of fabrication before and after swaging,respectively.

FIG. 18A is a top perspective view of a particular alignment plate.

FIG. 18B-18F illustrate schematic views of steps in a method offabrication.

FIG. 19A illustrates a schematic view of a support structure in aflattened configuration.

FIGS. 19B-19F illustrate schematic views of steps in a method offabrication.

FIGS. 20A-20B are top perspective illustrations of methods offabricating a support structure with a skirt.

FIGS. 21A and 21B depict an embodiment of backing and cover platesconfigured for assembling a medical device. FIG. 21C depicts anembodiment of an optional shim or protective insert usable with thebacking and cover plates in FIGS. 21A and 21B.

FIGS. 22A and 22B depict an embodiment of a seal material and valveleaflets for a valve of a medical device.

FIGS. 23A to 23Q are schematic illustrations of another embodiment formanufacturing a medical device.

DETAILED DESCRIPTION

Particular embodiments of the invention include endoluminal supportstructures (stents) and prosthetic valves. Described herein areendoluminal support structures and valve support structures comprising aplurality of strut members interconnected by articulated joints. Thesupport structures may have a generally cylindrical or tubular shape andmay comprise longitudinal axes. The support structures described herein(e.g., support structures 10, 10′, 2510, 2710, 3910, 3810, 4610) may beincrementally and reversibly expandable and collapsible between anexpanded configuration (i.e., having a greater radius orthogonal to thelongitudinal axis) and a compressed or collapsed configuration (i.e.,having a smaller radius orthogonal to the longitudinal axis). Thelongitudinal distances between two strut members may be less in theexpanded configuration than in the compressed configuration, while thecircumferential distances between two strut members may be greater inthe expanded configuration than in the compressed configuration.Similarly, the longitudinal distances between two articulated joints maybe less in the expanded configuration than in the compressedconfiguration, while the circumferential distances between twoarticulated joints may be greater in the expanded configuration than inthe compressed configuration. When compressed, the support structuresmay be at their maximum length and minimum diameter. When expanded, thesupport structures may be at their minimum length and maximum diameter.The maximum length may be limited by the length of the strut members,while the minimum diameter may be limited by the width of the strutmembers. In compressed configurations, the support structure may behighly compact. However, they may retain an open lumen through themwhile in the compressed configurations.

The strut members may be connected such that the support structures maybe moved from compressed configurations to expanded configurations, andthe reverse, by a number of different force configurations. For example,the support structures may be moved from an expanded configuration to acompressed configuration by application of radially inward force. Theradially inward force may be applied around the full circumference ofthe support structure, or it may be applied to fewer discrete pointsabout the circumference of the support structure (e.g., two opposingpoints about the circumference of the support structure, such as twoarticulated joints on the same diameter of the support structure).Similarly, the support structure may be moved from a compressedconfiguration to an expanded configuration by application of radiallyoutward force. The radially outward force may be applied around the fullcircumference of the support structure, or it may be applied to fewerdiscrete points about the circumference of the support structure (e.g.,two opposing points about the circumference of the support structure,such as two articulated joints on the same diameter of the supportstructure).

The support structure may also be moved from an expanded configurationto a compressed configuration by application of longitudinally orientedforces (i.e., force parallel to the longitudinal axis of the supportstructure) urging two strut members longitudinally away from each other.The support structure may similarly be moved from a compressedconfiguration to an expanded configuration by application oflongitudinally oriented forces urging two strut members longitudinallytoward each other. The application of longitudinally oriented forces attwo points may be sufficient to move the support structure from acompressed configuration to an expanded configuration or from anexpanded configuration to a compressed configuration.

The support structure may also be moved from an expanded configurationto a compressed configuration by application of circumferentiallyoriented forces urging two strut members circumferentially toward eachother. The support structure may similarly be moved from a compressedconfiguration to an expanded configuration by application ofcircumferentially oriented forces urging two strut memberscircumferentially away from each other. The application ofcircumferentially oriented forces at two points may be sufficient tomove the support structure from a compressed configuration to anexpanded configuration or from an expanded configuration to a compressedconfiguration. In some variations, the forces described above may beapplied by an actuator (such as those described herein), and thus anactuator may be used to move the support structure between compressedand expanded configuration, as described in more detail below.

The support structures may comprise a chain of linkages, which may beconfigured such that the expansion or compression of any individuallinkage, in the manner described above, may cause the other linkages toalso expand or compress. In such a way, the support structures may bereversibly expanded or compressed by application of force two only twopoints on the support structure (e.g., force urging two articulatedjoints apart or towards each other along a longitudinal axis, or forceurging two articulated joints apart or towards each other along thecircumference of the support structure).

The articulated joints of the support structures described herein maycomprise two or more (e.g., three, four, five, six, or more) separatecomponents that may articulate. The articulated joints may in somevariations be rotatable joints, such that the two or more components mayrotate in one or more planes relative to each other. In some variations,the rotatable joints may be pin joints, such that the two or morecomponents may rotate within a single plane (i.e., single-axis rotation)relative to each other. The axes of rotation of the articulated jointsmay be perpendicular to the longitudinal axes of the support structures.In some variations, the articulated joints may comprise primary axes ofrotation, but may also allow some movement along one or more additionalaxes (e.g., perpendicular to the primary axis of rotation). In some ofthese variations, the support structures may comprise longitudinal axes,and the primary axes of rotation of the articulated joints may beperpendicular to the longitudinal axes of the support structures.

This type of articulation may be achieved by any number of methods ofinterconnection between strut members, but in some variations may usefasteners such as rivets, eyelets, capped pins, screws, bolts,ball-in-socket structures, or nails, which may be integrally formed inthe struts (such as a peened semi-sphere interacting with an indentationor orifice, or a male-female coupling) or may be a separate structure.In some variations, the fasteners may be received by orifices spacedalong the length of the strut members. The orifices may be countersunkon one side of the strut members to receive the head of a fastener. Insome variations the orifices may be of uniform diameter and spacingalong the strut member, but neither is required. In addition to beingconfigured to receive fasteners, the orifices may provide an additionalpathway for tissue growth-over to stabilize and encapsulate the supportstructure over time.

Endoluminal Support Structures

FIG. 1A is a perspective view of a particular endoluminal supportstructure. As shown, the support structure 10 is a medical stent thatincludes a plurality of longitudinal strut members 11 interconnected bya plurality of articulated joints 15. In particular, the articulatedjoints 15 may allow the interconnected strut members 11 to rotaterelative to each other. The articulated joints may be able to be rotatedabout an axis of rotation, and/or may be swivelable. As shown, there areeighteen struts 11.

The support structure 10 may have a generally cylindrical shape, with alongitudinal axis 20. The articulated joints may have an axis ofrotation perpendicular to the longitudinal axis 20 of the supportstructure 10. In some variations, the articulated joints may also allowrotation about other axis, while in other variations, the articulatedjoints may be pin joints allowing rotation about only a single axisperpendicular to the longitudinal axis, as described in more detailabove. The support structure 10 may be incrementally and reversiblyexpandable and collapsible between an expanded configuration, as shownin FIG. 1D, and a compressed or collapsed configuration, as shown inFIG. 1C, as described in more detail above. The strut members 11 may beconnected such that the support structure 10 may be moved from thecompressed configuration to the expanded configuration, and the reverse,by a number of different force configurations, including radially,longitudinally, and circumferentially directed force, as described inmore detail above.

The strut members 11 may have a bar shape and may have a front surface11 f and a back surface 11 b. The strut members 11 may be interconnectedby fasteners 25, described in more detail above. As described above,each strut member 11 may also include a plurality of orifices 13 spacedalong the length of the strut member 11. On the front surface 11 f, theorifices may be countersunk 17 to receive the head of a fastener. In aparticular embodiment, there are thirteen equally spaced orifices 13along the length of each strut member 11, but more or fewer orifices canbe used.

The strut members 11 can be arranged as a chain of four-bar linkages.FIG. 1B is a perspective view of a four strut section of the stent ofFIG. 1A. As shown, two outer strut members 11-1, 11-3 overlap two innerstrut members 11-2, 11-4, with their back surfaces in communication witheach other. In particular, the first strut member 11-1 may be rotatablyconnected to the second strut member 11-2 by a middle articulated joint15-1 using a rivet 25-1, which utilizes orifices 13 that bisect thestrut members 11-1, 11-2. Similarly, the third strut member 11-3 may berotatably connected to bisect the fourth strut member 11-4 by a middlearticulated joint 15-7 using a rivet 25-7. It should be understood thatthe middle articulated joints 15-1, 15-7 can function as a scissor jointin a scissor linkage or mechanism. As shown, the resulting scissor armsare of equal length. It should also be understood that the middlearticulated joint 15-1, 15-7 need not bisect the joined strut members,but can instead utilize orifices 13 offset from the longitudinal centersof the strut members resulting in unequal scissor arm lengths.

In addition to the middle scissor articulated joint 15-1, the secondstrut member 11-2 may be rotatably connected to the third strut member11-3 by a distal anchor articulated joint 15-5, located near the distalends of the strut members 11-2, 11-3. Similarly, the first strut member11-1 may be rotatably connected to the fourth strut member 11-4 by aproximal anchor articulated joint 15-3, located near the proximal endsof the strut members 11-1, 11-4. To reduce stresses on the anchor rivets25-3, 25-5, the distal and proximal ends of the struts 11 can be curvedor twisted to provide a flush interface between the joined struts. As aresult of these rotatable connections, the linkage can be reversiblyexpanded and compressed. When the linkage is laterally compressed, thetwo strut members 11-4 and 11-2 move to be directly adjacent to eachother, and the two strut members 11-3 and 11-1 move to be directlyadjacent to each other, such that center diamond-shaped opening issubstantially closed. When the linkage is laterally expanded, the centerdiamond-shaped opening is widened.

As can be seen, the support structure 10 (FIG. 1A) may be fabricated bylinking together a serial chain of scissor mechanisms. The chain maythen be wrapped to join the last scissor mechanism with the firstscissor mechanism in the chain. By actuating the linkage the links canbe opened or closed, which results in expanding or compressing the stent10 (FIG. 1A). FIG. 1C is a perspective view of a compressed supportstructure of FIG. 1A. When compressed, the stent 10 is at its maximumlength and minimum diameter. The maximum length may be limited by thelength of the strut members, which in a particular embodiment may be 15mm. The minimum diameter may be limited by the width of the strutmembers, which in a particular embodiment may be about 0.052 inch. Incompressed as shown in FIG. 1C, the support structure is highly compact.However, the support structure may retain an open lumen through it whilein the compressed state.

FIG. 1D is a perspective view of the support structure of FIG. 1A in afully expanded state. As shown, the fully expanded support structure 10forms a ring. Once in a fully expanded state, support structure 10 mayenter a locked state such that radial inward pressure does not cause thesupport structure to re-compress and the support structure 10 is in anunstressed state. The ring formed can be used as an annuloplasty ring.In particular, if one end of the stent circumference is attached totissue, the compression of the stent may enable the tissue to cinch.Because the stent may have the ability to have an incremental andreversible compression or expansion, the device could be used to providean individualized cinching of the tissue to increase the competency of aheart valve. This could be a useful treatment for mitral valve diseases,such as mitral regurgitation or mitral valve prolapse.

The dimensions of each strut can be chosen in accordance with itsdesired use (e.g., depending on the implant site). In a particularembodiment, each strut member may be about 0.001-0.100 inch thick. Moreparticularly, each strut can be about 0.01 inch thick. In a particularembodiment, each strut member may be about 0.01-0.25 inches wide andabout 0.25-3 inches long. More particularly, each strut can be about0.06 inches wide and about 0.5 inches long. However, the thickness,width, and length of the struts may be variable, as described below.

The strut members can however be of different geometries. For example,the struts can be non-flat structures. In particular, the struts caninclude a curvature, such as in a concave or convex manner inrelationship to the inner diameter of the stent structure. The strutscan also be twisted. The nonflatness or flatness of the struts can be aproperty of the material from which they are constructed. For example,the struts can exhibit shape-memory or heat-responsive changes in shapeto the struts during various states. Such states can be defined by thestent in the compressed or expanded configuration.

While the above-described embodiments have featured a support structurehaving linear strut bars and equal length scissor arms, other geometriesmay be employed. The resulting shape may be other than cylindrical andmay have different performance characteristics in certain applications.

FIG. 1A shows a serial chain of scissor mechanisms such that there areeighteen struts 11, but other numbers of struts 11 can be used,including more than eighteen struts or fewer than eighteen struts. FIG.2A, for example, shows a support structure 3010 with a serial chain ofscissor mechanisms having twelve struts 3011. Like support structure 10,the support structure 3010 may have a generally cylindrical shape, witha longitudinal axis 3020. The articulated joints may have an axis ofrotation perpendicular to the longitudinal axis 3020 of the supportstructure 3010. In some variations, the articulated joints may alsoallow rotation about other axis, while in other variations, thearticulated joints may be pin joints allowing rotation about only asingle axis perpendicular to the longitudinal axis, as described in moredetail above. The support structure 3010 may be incrementally andreversibly expandable and collapsible between an expanded configurationand a compressed or collapsed configuration, as described in more detailabove. The strut members 3011 may be connected such that the supportstructure 3010 may be moved from the compressed configuration to theexpanded configuration, and the reverse, by a number of different forceconfigurations, including radially, longitudinally, andcircumferentially directed force, as described in more detail above.

As shown in FIG. 2A, the struts 3011 need not have orifices. In othervariations, however, support structures having twelve struts as in FIG.2A may have orifices 3013, as shown in FIG. 2B. FIGS. 2A-2B also showstruts 3011 and 3011′, respectively, having an inward curvature. Inother variations, such as the variation shown in FIG. 2C, a supportstructure having twelve struts may have straight struts 3011″. Supportstructures 3010, 3011′, and 3011″, or support structures having othernumbers struts arranged in a similar serial chain of scissor mechanisms,can be reversibly expanded, reversibly compressed, fully expanded toform a ring, implanted, used with an actuator and control catheterassembly, and/or used to support a prosthetic valve in the same manneras support structure 10, described in detail herein.

FIG. 3 is a perspective view of the arrangement of strut members in aconical-shaped support structure configuration. In the conical structure10′, the strut members 11 may be arranged as shown in FIGS. 1A-1D,except that the middle scissor pivots may not bisect the struts. Inparticular, the middle scissor pivots (e.g. 15′-1, 15′-7) may divide thejoined strut members (e.g. 11′-1, 11′-2 and 11′-3, 11′4) into unequalsegments of 5/12 and 7/12 lengths. When fully assembled, the resultingsupport structure may thus conform to a conical shape when expanded. Forillustration purposes, the stent 10′ is shown with a single-threadedactuator rod 32′ (described in more detail below), but it is not arequired element for this stent embodiment.

The stent 10′ can also assume a cone shape in its expanded configurationby imposing a convex or concave curvature to the individual strutmembers 11 that comprise the stent 10′. This could be achieved by usinga material with memory, such as shape-memory or temperature sensitiveNitinol.

A valve can be orientated in the cone-shaped stent 10′ such that thebase of the valve was either in the narrower portion of the cone-shapedstent, with the nonbase portion of the valve in the wider portion of thecone. Alternatively, the base of the valve can be located in the widestportion of the stent with the non-base portion of the valve in theless-wide portion of the stent.

The orientation of a cone-shaped stent 10′ in the body can be eithertowards or away from the stream of blood flow. In other body lumens(e.g. respiratory tract or gastrointestinal tract), the stent could beorientated in either direction, in relationship to the axial plane.

FIG. 4 shows another example of an endoluminal support structure 3810with a serial chain of scissor mechanisms having twelve strut members3811. The support structure 3810 may have a generally cylindrical shape,with a longitudinal axis 3820. The strut members may be interlinked byarticulated joints. The articulated joints may have an axis of rotationperpendicular to the longitudinal axis 3820 of the support structure3810. In some variations, the articulated joints may also allow rotationabout other axis, while in other variations, the articulated joints maybe pin joints allowing rotation about only a single axis perpendicularto the longitudinal axis, as described in more detail above. The supportstructure 3810 may be incrementally and reversibly expandable andcollapsible between an expanded configuration and a compressed orcollapsed configuration, as described in more detail above. The strutmembers may be connected such that the support structure 3810 may bemoved from the compressed configuration to the expanded configuration,and the reverse, by a number of different force configurations,including radially, longitudinally, and circumferentially directedforce, as described in more detail above.

Like the stent of FIGS. 1A-1D, the support structure 3810 may comprise achain of four-bar linkages, each comprising two inner strut members 3811and two outer strut members 3811 interconnected by fasteners 3825, asdescribed in more detail above. The strut members 3811 may have orifices3813. In each four-bar linkage, the first strut member 3811-1 (an innerstrut member) may be rotatably connected to the second strut member3811-2 (an outer strut member) by an articulated joint 3815-1 using arivet 3825-1, which may utilize orifices 3813 located at points spacedapart from the proximal and distal ends of the strut members 3811-1,3811-2. Similarly, the third strut member 3811-3 (an inner strut member)may be rotatably connected to the fourth strut member 3811-4 (an outerstrut member) by an articulated joint 3815-7 using a rivet 3825-7, whichmay utilize orifices 3813 located at points spaced apart from theproximal and distal ends of the strut members 3811-3, 3811-4. It shouldbe understood that the articulated joints 3815-1, 3815-7 may thusfunction as a scissor joint in a scissor linkage or mechanism. As shown,the resulting scissor arms are of equal length. It should also beunderstood that the joints 3815-1, 3815-7 may utilize orifices 3813offset from the longitudinal centers of the strut members, resulting inunequal scissor arm lengths, or may bisect the joined strut members,resulting in scissor arms of equal lengths.

In addition to the scissor articulated joint 3815-1, the second strutmember 3811-2 may be rotatably connected to the third strut member3811-3 by an articulated joint 3815-5 using rivet 3825-5. Whereas in thefour-bar linkages of the stent of FIGS. 1 and 2A-2C, the articulatedjoint 15-5 is an anchor joint (i.e., it is located near the distal endsof the strut members 11-2, 11-3), the strut members 3811-2, 3811-3extend distally beyond the articulated joint 3815-5. Strut members3811-2, 3811-3 may thus be longer than strut members 3811-1, 3811-4. Thefirst strut member 3811-1 may be rotatably connected to the fourth strutmember 3811-4 by a proximal anchor articulated joint 3815-3 using rivet3825-3, located near the proximal ends of the strut members 3811-1,3811-4. The strut members 3811 may be curved. As a result of theserotatable connections, the linkage can be reversibly expanded andcompressed. When the linkage is laterally compressed, the two strutmembers 3811-2 and 3811-4 move to be closer to each other, and the twostrut members 3811-1 and 3811-3 move to be closer to each other, suchthat center diamond-shaped opening is substantially closed. When thelinkage is laterally expanded, the center diamond-shaped opening iswidened.

The linkages may be combined into a continuous chain to form a supportstructure. In the variation of FIG. 4, three linkages may be combined toform support structure 3810. The linkages may be combined by connectingstrut member 3811-1 of one linkage with strut member 3811-4 of anotherlinkage at an articulated joint 3815-9 using rivet 3825-9; by connectingstrut member 3811-2 of one linkage with strut member 3811-3 of anotherlinkage at articulated joint 3815-11 using rivet 3825-11. Once combined,the continuous chain may be configured such that the expansion orcompression of any individual linkage, in the manner described above,may cause the other linkages to also expand or compress. In such a way,the support structure 3810 may be reversibly expanded or compressed byapplication of force two only two points on the support structure 3810(e.g., force urging two articulated joints apart or towards each otheralong a longitudinal axis, or force urging two articulated joints apartor towards each other along the circumference of the support structure).

FIG. 5 shows another example of an endoluminal support structure 3910with a serial chain of scissor mechanisms having twelve struts 3911. Thesupport structure 3910 may have a generally cylindrical shape, with alongitudinal axis 3920. The strut members may be interlinked byarticulated joints. The articulated joints may have an axis of rotationperpendicular to the longitudinal axis 3920 of the support structure3910. In some variations, the articulated joints may also allow rotationabout other axis, while in other variations, the articulated joints maybe pin joints allowing rotation about only a single axis perpendicularto the longitudinal axis, as described in more detail above. The supportstructure 3910 may be incrementally and reversibly expandable andcollapsible between an expanded configuration and a compressed orcollapsed configuration, as described in more detail above. The strutmembers 3911 may be connected such that the support structure 3910 maybe moved from the compressed configuration to the expandedconfiguration, and the reverse, by a number of different forceconfigurations, including radially, longitudinally, andcircumferentially directed force, as described in more detail above.

The support structure 3910 may comprise a chain of four-bar linkages,each comprising strut members 3911 interconnected by articulated joints3815 using fasteners 3925, as described in more detail above. The strutmembers may have a coating, described in more detail below. The four-barlinkages may each comprise two outer strut members (3911-2, 3911-4), andtwo inner strut members (3911-1, 3911-3), where each of the outer strutmembers may be connected to two inner strut members and no outer strutmembers, and each of the inner strut members may be connected to twoouter strut members and no inner strut members. The four-bar linkagesmay be combined by connecting each of the outer strut members to twomore inner strut members, such that each outer strut member is connectedto four inner strut members and no outer strut members, and by connectedeach of the inner strut members to two more outer strut members, suchthat each inner strut member is connected to four outer strut membersand no inner strut members. It should be appreciated that in othervariations, the number of connections may be greater, such that eachouter strut member may be connected to greater than four inner strutmembers, and each inner strut member may be connecter to great than fourouter strut members. More specifically, the first strut member 3911-1may be rotatably connected to the second strut member 3911-2 by anarticulated joint 3915-1 using a rivet 3925-1, which may utilizeorifices 3913 located at points spaced apart from the proximal anddistal ends of the strut members 3911-1, 3911-2. Similarly, the thirdstrut member 3911-3 may be rotatably connected to the fourth strutmember 3911-4 by an articulated joint 3915-7 using a rivet 3925-7, whichmay utilize orifices 3913 located at points spaced apart from theproximal and distal ends of the strut members 3911-3, 3911-4. It shouldbe understood that the articulated joints 3915-1, 3915-7 may thusfunction as a scissor joint in a scissor linkage or mechanism.Similarly, the second strut member 3911-2 may be rotatably connected tothe third strut member 3911-3 by an articulated joint 3915-5 using arivet 3925-5, located at points spaced apart from the proximal anddistal ends of the strut members 3911-2, 3911-3, but distal toarticulated joints 3915-1 and 3915-7. In addition, the first strutmember 3911-1 may be rotatably connected to the fourth strut member3911-4 by a proximal anchor articulated joint 3915-3 using rivet 3925-3,located near the proximal ends of the strut members 3911-1, 3911-4.

The strut members 3911 may be curved inwardly in a helical fashion. As aresult of these rotatable connections, the linkage can be reversiblyexpanded and compressed. When the linkage is laterally compressed, thetwo strut members 3911-4 and 3911-2 move to be closer to each other, andthe two strut members 3911-3 and 3911-1 move to be closer to each other,such that center diamond-shaped opening is substantially closed. Whenthe linkage is laterally expanded, the center diamond-shaped opening iswidened. Unlike the strut members of FIGS. 1A-1D, however, strut members3911-1 and 3911-4 may be longer than strut members 3911-2, 3911-3, suchthat when three four-bar linkages are linked to form support structure3910, the ends of strut members 3911-1, 3911-4 extend beyond thearticulated joints linking the four-bar linkages, as shown in FIG. 5.

The linkages may be combined into a continuous chain to form a supportstructure. In the variation of FIG. 5, three linkages may be combined toform support structure 3910. The linkages may be combined by connectingstrut member 3911-1 of one linkage with strut member 3911-4 of anotherlinkage at an articulated joint 3915-9 using rivet 3925-9 at locationsspaced away from the distal end of strut members 3911-1 and 3911-4; byconnecting strut member 3911-2 of one linkage with strut member 3911-3of another linkage at articulated joint 3915-11 using rivet 3925-11 at alocation at the distal ends of strut members 3911-2 and 3911-3; byconnecting strut member 3911-3 of one linkage with strut member 3911-4of another linkage at an articulated joint 3915-13 using rivet 3925-13at a location at the distal end of strut member 3911-3 and spaced awayfrom the distal end of strut member 3911-4; and by connecting strutmember 3911-1 of one linkage with strut member 3911-2 of another linkageat an articulated joint 3915-15 using rivet 3925-15 at a location at thedistal end of strut member 3911-2 and spaced away from the distal end ofstrut member 3911-1 but distal to articulated joint 3915-9. Oncecombined, the continuous chain may be configured such that the expansionor compression of any individual linkage, in the manner described above,may cause the other linkages to also expand or compress. In such a way,the support structure 3910 may be reversibly expanded or compressed byapplication of force two only two points on the support structure 3910(e.g., force urging two articulated joints apart or towards each otheralong a longitudinal axis, or force urging two articulated joints apartor towards each other along the circumference of the support structure).

The dimensions of each strut can be chosen in accordance with itsdesired use (e.g., depending on the implant site). In a particularembodiment, each strut member may be about 0.001-0.100 inches thick.More particularly, each strut may be about 0.01 inches thick. In othervariations, some struts may be thinner than other struts, which mayprovide increased flexibility. In a particular embodiment, each strutmay be about 0.01-0.25 inches wide. More particularly, each strut may beabout 0.06 inches wide. However, the thickness, width, and length of thestruts may be variable, as described below.

As shown, each strut member may be bar shaped. The strut members canhowever be of different geometries. For example, instead of a uniformwidth, a strut can vary in width along its length. Furthermore, anindividual strut can have a different width than another strut in thesame deployment structure. Similarly, the strut lengths can vary fromstrut to strut within the same deployment structure. The particulardimensions can be chosen based on the implant site. Furthermore, thestruts can be non-flat structures. In particular, the struts can includea curvature, such as in a concave, or convex manner in relationship tothe inner diameter of the deployment structure. The struts can also betwisted. The nonflatness or flatness of the struts can be a property ofthe material from which they are constructed. For example, the strutscan exhibit shape-memory or heat-responsive changes in shape to thestruts during various states. Such states can be defined by thedeployment structure in the compressed or expanded configuration.

In other embodiments, articulated support structures may comprise bowstruts, as described in PCT/US13/21052, 61/585,165, 61/780,670, whichare hereby fully incorporated by reference. In yet other embodiments,articulated support structures may comprise longer struts with more thanone middle articulation and end articulations, as described in PCT/US13/21052, 61/585,165, 61/780,670. In yet other embodiments, articulatedsupport structures may comprise radial struts, as described inPCT/US13/21052, 61/585,165, 61/780,670.

It should be noted that any of the above-described support structuresmay be extended beyond the anchor joints at either of both ends of thestent. By coupling a series of stents in an end-to-end chain fashion,additional stent lengths and geometries can be fabricated. Inparticular, an hourglass-shaped stent could be achieved by joining twocone-shaped stents at their narrow ends.

Valve Support Structures

Described herein are also valve support structures. These supportstructures may have similar designs and features to the endoluminalsupport structures described above, but may comprise commissure strutmembers configured to have attached valve leaflets. In general, thecommissure strut members may extend distally beyond the distal ends ofthe longitudinal strut members, and may be configured to support valveleaflets in a way that allows the leaflets to form a shape suitable fora prosthetic valve.

FIG. 6A is a perspective view of a support structure to which a tissuevalve may be mounted. The support structure 2510 may have a generallytubular shape comprising a proximal opening 2520, distal opening 2530,and a lumen 2540 therebetween. The tubular shape may be shorter and ringlike as in the support structure 2510 in FIG. 6A, or in other variationsit may be elongate. The support structure 2510 may have a longitudinalaxis 2550 and may comprise a plurality of strut members interlinked byarticulated joints. The articulated joints may have an axis of rotationperpendicular to the longitudinal axis 2550 of the support structure2510. In some variations, the articulated joints may also allow rotationabout other axis, while in other variations, the articulated joints maybe pin joints allowing rotation about only a single axis perpendicularto the longitudinal axis, as described in more detail above. The supportstructure 2510 may be incrementally and reversibly expandable andcollapsible between an expanded configuration and a compressed orcollapsed configuration, as described in more detail above. The strutmembers may be connected such that the support structure 2510 may bemoved from the compressed configuration to the expanded configuration,and the reverse, by a number of different force configurations,including radially, longitudinally, and circumferentially directedforce, as described in more detail above.

The support structure 2510 may comprise a plurality of longitudinalstrut members 2511 and a plurality of commissure strut members 2519. Thelongitudinal strut member 2511 and commissure strut members 2519 may beinterconnected by a plurality articulations comprising pin orarticulated joints 2515. The commissure strut members 2519 and theirarticulations may permit regions of the support structure to extendfurther beyond the structure provided by the longitudinal strut members2511, and which may expand and contract along with the configurationalchanges to the longitudinal strut members 2511, without generatingsignificantly more resistance or stress in the structure, if any. Asshown, there are eighteen struts 2511 and six struts 2519. Thearticulated joints 2515 may have an axis of rotation with a radialorientation and which may allow the interconnected strut members 2511and 2519 to rotate relative to each other. One set of articulated joints2515 connecting longitudinal strut members 2511 may be located at theproximal ends of longitudinal strut members 2511 in a plane aligned withthe proximal opening 2520. A second set of articulated joints 2511connecting longitudinal strut members 2511 may be located at the distalends of longitudinal strut members 2511 in a plane aligned with thedistal opening 2530. A third set of articulated joints 2515 connectinglongitudinal strut members 2511 may be located between the proximalopening 2520 and the distal opening 2530. A fourth set of articulatedjoints 2515 connecting commissure strut members 2519 may be locateddistal to the plane of distal opening 2530. A fifth set of articulatedjoints 2515 connecting longitudinal strut members 2511 to commissurestrut members 2519 may be located proximal to the plane of distalopening 2530 between the third set of articulated joints 2515 and theplane of distal opening 2530.

The dimensions of each strut can be chosen in accordance with itsdesired use (e.g., depending on the implant site). In a particularembodiment, each longitudinal strut members may be about 0.001-0.100inch thick. More particularly, each strut may be about 0.01 inch thick.In a particular embodiment, each longitudinal strut members 2511 may beabout 0.01-0.25 inches wide. More particularly, each longitudinal strutmembers 2511 may be about 0.06 inches wide. However, the thickness,width, and length of the longitudinal strut members 2511 may bevariable, as described below. In a particular embodiment, eachcommissure strut member 2519 may be about 0.001-0.100 inches thick. Moreparticularly, each commissure strut member 2519 may be about 0.01 inchesthick. In a particular embodiment, each commissure strut member 2519 maybe about 0.01-0.25 inches wide. More particularly, each commissure strutmember 2519 may be about 0.06 inches wide. However, the thickness,width, and length of the commissure strut members 2519 may be variable,as described below. Moreover, the thickness and/or material of thecommissure strut members 2519 may be such that the commissure strutmembers 2519 are more flexible than the longitudinal strut members 2511,such as by being thinner or by being made of a more flexible material.

As shown, each longitudinal strut member 2511 is bar shaped and has afront surface 2511 f and a back surface 2511 b; and each commissurestrut member 2519 is bar shaped and has a front surface 2519 f and aback surface 2519 b. The strut members can, however, optionally comprisedifferent geometries. For instance, the longitudinal struts 2511 andcommissure struts 2519 can be non-flat structures. In particular, thestruts can include a curvature, such as in a concave or convex manner inrelationship to the inner diameter of the support structure 2510. Thestruts can also be twisted. The nonflatness or flatness of the strutscan be a property of the material from which they are constructed. Forexample the struts can exhibit shape-memory or heat responsive changesin shape to the struts during various states. Such states can be definedby the support structure in the compressed or expanded configuration.The struts can also exhibit changes in shape due to stressed on themwhile implanted. For instance, if used to support a prosthetic valveassembly as described in detail below, the stress on the commissurestruts 2519 during the normal cardiac cycle may cause the commissurestruts 2519 to permanently or temporarily bend or otherwise changeshape. In variations in which the commissure strut members 2519 arefabricated from biocompatible materials having greater flexibility thanthe materials from which the longitudinal strut members 2511 arefabricated, if a force including a radially inward component is appliedto the commissure strut members, they may flex inward, while thelongitudinal strut members 2511 may not substantially deform.

Each longitudinal strut member 2511 may also include a plurality oforifices 2513 spaced along the length of strut members 2511, asdescribed above. On the front surface 2511 f, orifices may becountersunk to receive the head of a fastener. FIG. 6A shows commissurestrut members 2519 as not having orifices 2513 along their lengths.However, in other instances, the commissure strut members 2519 may haveorifices 2513 along their lengths. Orifices 2513 on commissure strutmembers 2519 can similarly be countersunk on front surface 2519 f toreceive the head of a fastener. In the support structure of FIG. 6A,longitudinal strut members 2511-1 and 2511-4 (FIG. 6B) may have thirteenorifices 2513 and longitudinal strut members 2511-2 and 2511-3 (FIG. 6B)may have ten orifices 2513. There can, however, be more or fewerorifices on longitudinal strut members 2511.

The strut members 2511 and 2519 may be arranged as a chain of four- andsix-bar linkages, and wherein at least some, if not all, of the linkagesets share common struts with adjacent linkages and configurationchanges to one linkage will generate complementary changes to the otherlinkages linked by common struts. Complementary changes, however, arenot necessarily limited to linkages or struts with common struts. Thefour-bar linkages may have the same configuration as the four strutsection of the stent of FIG. 1B, described in detail above. FIG. 6B is aperspective view of a six-bar linkage of the support structure of FIG.10A. As shown, two outer strut members 2511-1, 2511-3 overlap two innerstrut members 2511-2, 2511-4, with their back surfaces in communicationwith each other. In addition, two commissure strut members-outercommissure strut member 2519-1 and inner commissure strut member2519-2—can be connected to inner strut member 2511-2 and outer strutmember 2511-3. The strut members 2511, 2519 may be interconnected byfasteners 2525, as described above, extending through aligned orifices.

In particular, the outer strut member 2511-1 may be rotatably orswivelably connected to the inner strut member 2511-2 by an articulatedjoint 2515-1 using a rivet 2525-1, which utilizes orifices 2913. Thearticulated joint 2515-1 may bisect outer strut member 2511-1. Thearticulated joint 2515-1 may not bisect inner strut member 2511-2, butinstead utilize an orifice 2513 that is offset distally from thelongitudinal center of inner strut member 2511-2. It should beunderstood that the articulated joint 2515-1 may utilize differentorifices 2513 than the ones shown in FIG. 6B.

The outer strut member 2511-3 may be rotatably connected to the innerstrut member 2511-4 by an articulated joint 2515-7 using a rivet 2525-7,which utilizes orifices 13. The articulated joint 2515-7 may bisectinner strut member 2511-4. The articulated joint 2525-7 may not bisectouter strut member 2511-3, but instead utilize an orifice 2513 that isoffset distally from the longitudinal center on outer strut member2511-3. It should be understood that the articulated joint 2515-7 mayutilize different orifices 2513 than the ones shown in FIG. 6B.

In addition to the articulated joint 2515-1, the outer strut member2511-1 may be rotatably connected to the inner strut member 2511-4 by aproximal anchor articulated joint 2515-3 using rivet 2525-3, locatednear the proximal ends of the strut members 2511-1, 2511-4. The innerstrut member 2511-2 may also be rotatably connected to the commissurestrut member 2519-1 by an articulated joint 2515-9 using a rivet 2525-9,located near the distal end of inner strut member 2511-2 and theproximal end of commissure strut member 2519-1. Likewise, the outerstrut member 2511-3 may be rotatably connected to the commissure strutmember 2519-2 by an articulated joint 2515-11 using a rivet 2525-11,located near the distal end of outer strut member 2511-3 and theproximal end of commissure strut member 2519-2. Commissure strut member2519-1 may also be rotatably connected to commissure strut member 2519-2by a distal anchor articulated joint 2515-13 using rivet 2525-13,located near the distal ends of the commissure strut members 2519-1,2519-2.

To reduce stress on the anchor rivets 2525-3, 2525-13, the proximal endsof struts 2511-1, 2511-4 and distal ends of commissure struts 2519-1,2519-2 may be curved or twisted to provide a flush interface between thejoined struts.

As can be seen in FIG. 6A, the support structure 2510 may be fabricatedby linking together a chain of individual six-strut sections (FIG. 6B)and four-strut sections (FIG. 1B). The chain may then be wrapped orotherwise connected back to itself to join the last section with thefirst section in the chain. As shown in FIG. 6A, a chain of threesix-strut sections and six four-strut sections may be joined, such thatevery third section is a six-strut section. It should be understood thatdifferent numbers of four-strut sections may be linked with the threesix-strut sections. In some variations, the support structure may havezero four-strut sections and consist only of six-strut sections. As inthe support structure 10 shown in FIG. 1A, actuating the linkage maycause the links to be opened or closed, which may result in expanding orcompressing the support structure 2510 (FIG. 6A). When the supportstructure is in neither a fully expanded nor fully compressed state, theangle between commissure strut members 2519-1, 2519-2 at distal anchorarticulated joint 2515-13 may be less than the angle between twolongitudinal strut members 2511 at an anchor articulated joint 2515located near the distal ends of the two longitudinal strut members 2511.

Strut members 2511, 2519 may have lengths chosen based on the implantsite. In a particular embodiment, outer longitudinal strut 2511-1 andinner longitudinal strut 2511-4 may have approximately the same length,inner longitudinal strut 2511-2 and outer longitudinal strut 2511-3 mayhave approximately the same length, and commissure struts 2519-1, 2519-2may have approximately the same length. In that embodiment the length ofouter longitudinal strut 2511-1 and inner longitudinal strut 2511-4 maybe greater than the length of inner longitudinal strut 2511-2 and outerlongitudinal strut 2511-3. In that embodiment, the combined longitudinallength of longitudinal strut member 2511-2 and commissure strut member2519-1 may be greater than the length of longitudinal strut member2511-1 or longitudinal strut member 2511-4. In that embodiment, thecombined longitudinal length of longitudinal strut member 2511-3 andcommissure strut member 2519-2 may be greater than the length oflongitudinal strut member 2511-1 or longitudinal strut member 2511-4. Insome embodiments the combined length of longitudinal strut member 2511-2and commissure strut member 2519-1 may be at least 20% longer than thelength of longitudinal strut members 2511-1 or 2511-4. Similarly thecombined longitudinal length of longitudinal strut member 2511-3 andcommissure strut member 2519-2 may be at least 20% longer than thelength of longitudinal strut members 2511-1 or 2511-4. Distal anchorarticulated joint 2515-13, located near the distal ends of commissurestrut members 2519-1 and 2519-2 may extend beyond the plane of thedistal opening 2530 by a longitudinal distance that is at least 20% ofthe longitudinal distance between the planes of the proximal opening2520 and distal opening 2530. In one embodiment outer longitudinal strut2511-1 and inner longitudinal strut 2511-4 may be about 0.250-3.00inches long; inner longitudinal strut 2511-2 and outer longitudinalstrut 2511-3 may be about 0.1-2.5 inches long; and commissure struts2519-1, 2519-2 may be about 0.1-2.5 inches long. More particularly,outer longitudinal strut 2511-1 and inner longitudinal strut 2511-4 maybe about 0.5 inches long; inner longitudinal strut 2511-2 and outerlongitudinal strut 2511-3 may be about 0.375 inches long; and commissurestruts 2519-1, 2519-2 may be about 0.2 inches long.

The diameter of support structure 2510 can be chosen based on theimplant site. In a particular embodiment for implantation at the mitralvalve opening, the diameter may be about 0.5-1.55 inches. Moreparticularly, the diameter may be about 0.8 inches.

FIG. 7A is a perspective view of another articulated support structureto which a tissue valve may be able to be mounted. The support structuremay have a tubular shape having a proximal opening 2720, distal opening2730, and a lumen 2740 therebetween. The tubular shape may be shorterand ring like as in the support structure 2710 in FIG. 7A, or in othervariations it may be elongate. The support structure 2710 may have alongitudinal axis 2750 and may comprise a plurality of strut membersinterlinked by articulated joints. The articulated joints may have anaxis of rotation perpendicular to the longitudinal axis 2750 of thesupport structure 2710. In some variations, the articulated joints mayalso allow rotation about other axis, while in other variations, thearticulated joints may be pin joints allowing rotation about only asingle axis perpendicular to the longitudinal axis, as described in moredetail above. The support structure 2710 may be incrementally andreversibly expandable and collapsible between an expanded configurationand a compressed or collapsed configuration, as described in more detailabove. The strut members may be connected such that the supportstructure 2710 may be moved from the compressed configuration to theexpanded configuration, and the reverse, by a number of different forceconfigurations, including radially, longitudinally, andcircumferentially directed force, as described in more detail above.

Like the support structure of FIG. 6A, support structure 2710 mayinclude a plurality of longitudinal strut members 2711 and commissurestrut members 2719 interconnected by a plurality of articulated joints2715. As shown, there are twelve struts 2711 and six struts 2719. Thearticulated joints 2715 may have an axis of rotation with radialorientation, which may allow the interconnected strut members 2711 and2719 to rotate relative to each other. One set of articulated joints2715 connecting longitudinal strut members 2711 may be located at theproximal ends of strut members 2711 in a plane aligned with proximalopening 2720. A second set of articulated joints 2711 connectinglongitudinal strut members 2711 to each other and to commissure strutmembers 2719 may be located at the distal ends of longitudinal strutmembers 2711 and the proximal ends of commissure strut members 2719 andin a plane aligned with the distal opening 2730. A third set ofarticulated joints 2711 connecting longitudinal strut members 2711 maybe located between the proximal opening 2720 and distal opening 2730 andproximal to the midpoint between the proximal opening 2720 and distalopening 2730. A fourth set of articulated joints 2711 may be locatedbetween the proximal opening 2720 and distal opening 2730 and distal tothe midpoint between the proximal opening 2720 and distal opening 2730.A fifth set of articulated joints 2711 connecting commissure strutmembers 2719 may be located distal to the plane of distal opening 2730.

The dimensions of each strut can be chosen in accordance with itsdesired use (e.g., depending on the implant site). In a particularembodiment, each longitudinal strut member 2711 may be about 0.001-0.100inches thick. More particularly, each longitudinal strut member 2711 maybe about 0.01 inches thick. In a particular embodiment, eachlongitudinal strut member 2711 may be about 0.01-0.25 inches wide. Moreparticularly, each longitudinal strut member 2711 may be about 0.06inches wide. In a particular embodiment, each commissure strut member3719 may be about 0.001-0.100 inch thick. More particularly, eachcommissure strut member 3719 may be about 0.01 inches thick. In aparticular embodiment, each commissure strut member 2719 may be about0.010-0.250 inches wide. More particularly, each commissure strut member2719 may be about 0.06 inches wide. However, the thickness, width, andlength of the commissure strut members 2719 may be variable, asdescribed below. Moreover, the thickness and/or material of thecommissure strut members 2719 may be such that the commissure strutmembers 2719 are more flexible than the longitudinal strut members 2711,such as by being thinner or by being made of a more flexible material.

As shown, each longitudinal strut member 2711 is bar shaped and has afront surface 2711 f and a back surface 2711 b; and each commissurestrut member 2719 is bar shaped and has a front surface 2719 f and aback surface 2719 b. The strut members may, however, be of differentgeometries. For instance, the longitudinal struts 2711 and commissurestruts 2719 can be non-flat structures. In particular, the struts caninclude a curvature, such as in a concave or convex manner inrelationship to the inner diameter of the support structure 2710. Thestruts can also be twisted. The nonflatness or flatness of the strutscan be a property of the material from which they are constructed. Forexample the struts can exhibit shape-memory or heat responsive changesin shape to the struts during various states. Such states can be definedby the support structure in the compressed or expanded configuration.The struts can also exhibit changes in shape due to stressed on themwhile implanted. For instance, if used to support a prosthetic valveassembly as described in detail below, the stress on the commissurestruts 2719 during the normal cardiac cycle may cause the commissurestruts 2719 to permanently or temporarily bend or otherwise changeshape. In variations in which the commissure strut members 2719 arefabricated from biocompatible materials having greater flexibility thanthe materials from which the longitudinal strut members 2711 arefabricated, if a force including a radially inward component is appliedto the commissure strut members 2719, they may flex inward, while thelongitudinal strut members 2711 may not substantially deform.

Each longitudinal strut member 2711 may also include a plurality oforifices 2713 spaced along the length of strut members 2711, asdescribed above. On the front surface 2711 f, orifices may becountersunk to receive the head of a fastener. FIG. 7A shows commissurestrut members 2719 as not having orifices 2713 along their lengths.However, in other instances the commissure strut members 2719 may haveorifices 2713 along their lengths, as shown in the variation in FIG. 7B.Orifices 2713 on commissure strut members 2719 may similarly becountersunk on front surface 2719 f to receive the head of a fastener.In FIG. 7A, longitudinal strut members 2711 have five orifices 2713.There can, however, be more or fewer orifices on longitudinal strutmembers 2711. For example, in another embodiment, longitudinal struts2711-2, 2711-3 may have four orifices 2713, and longitudinal struts2711-1, 2711-4 may have no orifices. In another embodiment, longitudinalstruts 2711-2, 2711-3 may have no orifices, and longitudinal struts2711-1, 2711-4 may have four orifices 2713.

The strut members 2711 and 2719 may be arranged as a chain of threesix-strut elements. Each six-strut element may contain two outer strutmembers 2711-1, 2711-3, which overlap two inner strut members 2711-2,2711-4, with their back surfaces in communication with each other. Inaddition, each inner and outer strut member may be connected to one oftwo commissure strut members-outer commissure strut member 2719-1 orinner commissure strut member 2719-2. The strut members 2711, 2719 maybe interconnected by fasteners 2725, as described in more detail above,extending through aligned orifices.

In particular, the outer strut member 2711-1 may be rotatably connectedto the inner strut member 2711-2 by a distal articulated joint 2715-2using rivet 2725-2, located near the distal ends of the strut members2711-1, 2711-2. The outer strut member 2711-3 may be rotatably connectedto the inner strut member 2711-4 by a distal articulated joint 2715-3using rivet 2725-3, located near the distal ends of the strut members2711-3, 2711-4. The outer strut member 2711-3 may also be rotatablyconnected to the inner strut member 2711-2 by an articulated joint2715-1 using a rivet 2725-1, which utilizes orifices 2713. Thearticulated joint may be offset distally from the longitudinal center onboth outer strut member 2711-3 and inner strut member 2711-2. It shouldbe understood that the articulated joint 2715-1 may utilize differentorifices 2713 than the ones shown in FIG. 7A, including being offsetproximally from the longitudinal center.

The commissure strut member 2719-1 may be rotatably connected at itsproximal end to outer strut member 2711-1 and inner strut member 2711-2at articulated joint 2715-2 using rivet 2725-2. The commissure strutmember 2719-2 may be rotatably connected at its proximal end to outerstrut member 2711-3 and inner strut member 2711-4 at articulated joint2715-3 using rivet 2725-3.

Commissure strut member 2719-1 may be rotatably connected to commissurestrut member 2719-2 by a distal anchor articulated joint 2715-4 usingrivet 2725-4, located near the distal ends of the commissure strutmembers 2719-1, 2719-2.

As can be seen, the support structure 2710 may be fabricated by linkingtogether a chain of three six-strut elements, and wherein at least some,if not all, of the linkage sets share common struts with adjacentlinkages and configuration changes to one linkage will generatecomplementary changes to the other linkages linked by common struts.Complementary changes, however, are not necessarily limited to linkagesor struts with common struts. Two such elements may be connected byrotatably connecting the outer strut member 2711-1 of a first element tothe inner strut member 2711-2 of a second element by a proximal anchorarticulated joint 2715-5 using rivet 2725-5, located near the proximalends of strut member 2711-1 of the first element and strut member 2711-2of a second element. In addition, the outer strut member 2711-3 of thefirst element may be rotatably connected to the inner strut member2711-4 of the second element by a proximal anchor articulated joint2715-6 using rivet 2725-6, located near the proximal ends of strutmember 2711-3 of the first element and strut member 2711-4 of the secondelement. Outer strut member 2711-1 of the first element may also berotatably connected to inner strut member 2711-4 of the second elementby an articulated joint 2715-7 using rivet 2725-7, which utilizesorifices 2713. The articulated joint may be offset proximally from thelongitudinal center on both the outer strut member 2711-1 and innerstrut member 2711-4. It should be understood that articulated joint2715-7 may utilize different orifices 2713 than the ones shown in FIG.7A, including being offset distally from the longitudinal center. Athird element may be connected to the second element in the same manneras the second element is connected to the first element. The chain maythen be wrapped to join the third element with the first element in thesame manner.

When the support structure 2710 is in neither a fully expanded nor fullycompressed state, the angles between the commissure strut members2719-1, 2719-2 at distal anchor articulated joint 2715-4 may be lessthan the angle between two longitudinal strut members 2711 at otheranchor articulated joints 2715-2, 2715-3, 2715-5, and 2715-6. In theembodiment in FIG. 7A the angles between two longitudinal strut members2711 at anchor articulated joints 2715-2, 2715-3, 2715-5, and 2715-6 arethe same. In other embodiments the angles may be different.

Strut members 2711, 2719 may have lengths chosen based on the implantsite. In a particular embodiment, longitudinal strut members 2711 mayall have approximately the same length, and commissure strut members2719 may all have approximately the same length. In the variation shownin FIG. 7A, the commissure strut members 2719 have a shorter length thanlongitudinal strut members 2719. In other variations, the commissurestrut members 2719 may be longer than longitudinal strut members 2719.In one embodiment longitudinal strut members 2711 may be about 0.25-3inches long, and commissure strut members 2719 may be about 0.25-2inches long. More particularly, longitudinal strut members 2711 may beabout 1.75 inches long, and commissure strut members 2719 may be about 1inch long.

To reduce stress on the anchor rivets 2725-4, 2725-5, and 2725-6, theproximal ends of longitudinal strut members 2711 and distal ends ofcommissure strut members 2719 can be curved or twisted to provide aflush interface between the joined struts.

The diameter of support structure 2710 can be chosen based on theimplant site. In a particular embodiment for implantation at the mitralvalve opening, the diameter may be about 0.5-1.5 inches. Moreparticularly, the diameter may be about 0.8 inches. In anotherembodiment for implantation at the aortic valve opening, the diametermay be larger than the diameter of an embodiment for implantation at themitral valve opening. More particularly, the diameter may be about0.5-2.0 inches. In a particular embodiment, the diameter may be about 1inch. The diameter may be such that the valve is secured in the aorticvalve opening by exerting a strong outward radial force against thetissue, forming a friction fit.

In an embodiment at the aortic valve opening, the overall height of thevalve support structure may be less than the overall height of anembodiment for implantation at the mitral valve. In an embodiment theheight in the expanded configuration may be about 0.2-2.0 inches. Moreparticularly, the height in the expanded configuration may be about 0.6inches.

Actuators

The support structures described herein may have their diameterscompressed by utilizing the articulated joints for insertion through abiological lumen, such as an artery, to a selected position. The supportstructure can then be expanded to secure the support structure at theselected location. Furthermore, after being expanded, the selectedstructure can be recompressed for removal from the body or forrepositioning. Due to the properties of a scissor linkage wrapped into acylinder, actuators can exert force to expand the stent diameter byeither increasing the distance between neighboring scissor joints, anddecreasing the distance between the anchor joints.

The actuators may be attached to the support structures in any suitablemanner for reversibly moving the support structures between compressedand expanded configurations. In some variations, the actuator may beattached so as to apply longitudinally oriented forces urging two strutmembers longitudinally away or towards each other. In order to do so,the actuator may be attached to two longitudinally adjacent articulatedjoints; that is, the actuator is attached at two articulated jointslocated along the same longitudinal axis of the support structure. Inother variations, the actuator may be attached at points along the strutmembers not at the location of articulated joints. It should beappreciated that the actuator may be configured to apply longitudinallyoriented forces urging two strut members longitudinally away or towardseach other while being attached at an angle to the longitudinal axis. Insome variations, the actuator may be attached so as to applycircumferentially oriented forces urging two strut memberscircumferentially away or towards each other. In order to do so, theactuator may be attached to two circumferentially adjacent joints (e.g.,at scissor joints between strut members). In other variations, theactuator may be attached at points along the strut members not at thelocation of articulated joints. It should be appreciated that theactuator may be configured to apply circumferentially oriented forcesurging two strut members circumferentially away or towards each otherwhile being attached at an angle to a circumferential plane through thesupport structure (e.g. at an angle to a plane orthogonal to thelongitudinal axis of the support structure). In some variations, theactuator may be attached so as to apply radially oriented forces urgingtwo or more points on the support structure away or towards each other.It should also be appreciated that in some variations, the actuator maycomprise more than two ends, and may be attached to the supportstructure at more than two points. It should be appreciated that theactuator may be attached to the outside of the support structure, theinside of the support structure, or it may be attached in the same planeas the strut members.

While the support structures described herein may be able to beimplanted in a patient during an open operative procedure, a closedprocedure may also be desirable. As such, the support structures mayinclude an actuator to allow a surgeon to expand or compress the supportstructure from a location remote from the implant site. In a typicalprocedure, the support structures may be implanted through a body lumen,such as the femoral artery, using a tethered endoluminal catheter. Assuch, the actuators may be able to be controlled via a catheter.

FIG. 8A is a perspective view of a linkage of the support structure 10of FIG. 1B having a particular actuator. As shown, the actuator 30includes a dual-threaded rod 32 positioned on the inside of the supportstructure 10. It should be understood, however, that the actuator 30 caninstead be positioned on the outside of the support structure 10, orwithin the thickness of the strut members, instead of inside or outsideof the stent. Whether positioned on the inside or outside, the actuator30 may operate in the same way. The rod may include right-hand threads34R on its proximal end and left-hand threads 34L on its distal end. Therod 32 may be mounted the anchor articulated joints 15-3, 15-5 using apair of threaded low-profile support mounts 35-3, 35-5. Each end of therod 32 may be terminated by a hex head 37-3, 37-5 for receiving a hexdriver (not shown). As should be understood, rotating the rod 32 in onedirection may urge the anchor fasteners 25-3, 25-5 outwardly to compressthe linkages while rotating the rod 32 in the opposite direction mayurge the anchor fasteners 25-3, 25-5 inwardly to expand the linkages.

FIG. 9 is a perspective view of the support structure of FIG. 1A havinganother particular actuator. As shown, the actuator 30′ includes asingle-threaded rod 32′ positioned on the inside of the supportstructure 10 (FIG. 1A). The rod 32′ may include threads 34′ on one ofits ends. The rod 32′ may be mounted to low profile anchor articulatedjoints 15-3, 15-5 using a pair of support mounts 35′-3, 35′-5, one ofwhich is threaded to mate with the rod threads 34′. The unthreaded endof the rod 32′ may include a retaining stop 39′ that bears against thesupport mount 35′-5 to compress the support structure. Each end of therod 32′ can be terminated by a hex head 37′-3, 37′-5 for receiving a hexdriver (not shown). Again, rotating the rod 32′ in one direction mayurge the anchor fasteners 25-3, 25-5 outwardly to compress the linkageswhile rotating the rod 32′ in the opposite direction may urge the anchorfasteners 25-3, 25-5 inwardly to expand the linkages.

In a particular embodiment, the rod 32, 32′ may have a diameter of about1.0 mm and a thread count of about 240 turns/inch. By employing threads,the rod may be self-locking to maintain the support structure in thedesired diameter. In addition, because the struts overlap, a ratchetingmechanism can be incorporated to be utilized during the sliding of onestrut relative to the other. For example, the stent could lock atincremental diameters due to the interaction of features that are anintegral part of each strut. An example of such features would be a malecomponent (e.g. bumps) on one strut surface which mates with the femalecomponent (e.g. holes) on the surface of the neighboring strut surface,as the two struts slide pass one another. Such structures could befabricated to have an orientation, such that they incrementally lock thestent in the expanded configuration as the stent is expanded. Such astent could be expanded using a conventional balloon or other actuatordescribed in this application.

Because the support structure 10 may be configured to be implantedduring a closed surgical procedure, the actuator may be able to becontrolled remotely by a surgeon. FIG. 9 is a perspective view of aparticular support structure and control catheter assembly usable withthe actuators of FIGS. 8A-8B. The control catheter 40 may be dimensionedto be inserted with the support structure through a biological lumen,such as a human artery. As shown, the control catheter 40 includes aflexible drive cable 42 having a driver 44 on its distal end thatremovably mates with a hex head 37, 37′ of the actuator (FIGS. 8A-8B).The proximal end of the cable 42 can include a hex head 46. Inoperation, the proximal hex head 46 of the cable 42 may be rotated by asurgeon, using a thumb wheel or other suitable manipulator (not shown).Rotation of the hex head 46 may be transferred by the cable 42 to thedriver head 44 to turn the actuator rod 30, 30′ (FIGS. 8A-8B).

The cable 42 may be encased by a flexible outer sheath 48. The distalend of the outer sheath 48 may include a lip or protuberance 49 shapedto interface with the support structure 10. When the cable 42 is turned,the outer sheath lip 49 may interact with the support structure 10 tocounteract the resulting torque.

While a threaded rod and drive mechanism are described, other techniquescan be employed to actuate the linkages depending on the particularsurgical application. For example, worm gears or a rack and pinionmechanism can be employed as known in the art. One of ordinary skill inthe art should recognize other endoluminal actuation techniques. Inother situations, the support structure can be implanted during an openprocedure, which may not require an external actuator.

Although the actuators above are described with respect to use withsupport structure 10, similar actuators may be used with the othersupport structures and combinations of support structure describedherein (e.g., support structures 10, 10′, 2510, 2710, 3910, 3810, 4610and combinations thereof). For example, FIG. 10 shows an actuatorsimilar to the actuator of FIGS. 8A-8B attached to support structure3010. As shown, the actuator 4110 may have a rod-like shape. Theactuator may be attached to the support structure in any suitable mannerfor reversibly moving the support structure between compressed andexpanded configurations, as described in detail above. As shown in FIG.10, in one variation one end of the actuator 4110 may be attached to theinside of articulated joint 3015-5 of support structure 3010, and theother end of the actuator 4110 may be attached to the inside ofarticulated joint 3015-3 of support structure 3010. As shown, theactuator 4110 may comprise a rod having an adjustable length. The rodmay comprise two components interconnected by threading (e.g., amicroscrew); when two components are rotated relative to each other, thelength of the rod may be incrementally and reversibly adjustable betweenand extended configuration with a longer length and a collapsedconfiguration with a shorter length. Extending the length of the rod4110 may cause the joints to which the rod is attached to movelongitudinally away from each other, causing the support structure tocompress. Shortening the length of the rod may cause the joints to whichthe rod is attached to move longitudinally toward each other, causingthe support structure to expand. The actuator 4110 may be controlledremotely by a surgeon. In some variations, the actuator 4110 may be ableto be controlled via a catheter, such as the control catheters describedherein.

FIGS. 11A-11B show a rotary instrument 5010 for controlling an actuator,such as the actuators discussed above with respect to FIGS. 8A-18B, 9,and 10 from a location remote from the implant site. The rotaryinstrument 5010 may be configured to exert a rotational force. In somevariations, the rotary instrument 5010 may be configured to exertbi-directional force, and may have a low RPM. The rotary instrument 5010may comprise a control button 5012 that may be used to turn the rotaryinstrument 5010 on/off and/or to the control the speed and/or directionof the rotation. The proximal end 5014 of the rotary instrument 5010 maycomprise an attachment port for a catheter assembly 5016. The catheterassembly 5016 may comprise a flexible catheter having an outer sheath,as shown in FIG. 11B. The proximal end 5018 of the catheter may attachto an actuator, as shown in FIGS. 11C-11D. By rotating the microscrew ofthe actuator, as described in more detail above, the rotary instrumentmay allow for fine, incremental changes in the size of the supportstructure. The changes may be reversible, and may allow for continuousauto-locking at each size.

Valves

Although there are other uses for the support structures describedherein, such as drug delivery, in some variations, the supportstructures may be configured to support a prosthetic valve. Inparticular, the support structure may be used in combination with aprosthetic valve, such as for an aortic or mitral valve replacement.

The support structures may support prosthetic valves comprising aplurality of leaflets. The leaflets may be derived from a biocompatiblematerial or materials, which may be either biological or non-biological,or a combination. For example, the leaflets may comprise animalpericardium (e.g. bovine, porcine, equine), human pericardium,chemically treated pericardium, gluteraldehyde-treated pericardium,tissue engineered materials, a scaffold for tissue engineered materials,autologous pericardium, cadaveric pericardium, Nitinol, polymers,plastics, PTFE, or any other material known in the art.

As supported by the support structures described herein, the valves maybe configured to be actuated by utilizing the forces exerted by thenormal blood flow or pressure changes of the cardiac cycle. Morespecifically, the heart may eject blood through the fully open valve.Shortly thereafter, the distal or downstream blood pressure may start torise relative to the proximal pressure across the valve, which maycreate a backpressure on the valve. In considering the valve as anaortic valve replacement, it may remain closed until the heart enterssystole. During systole, as the myocardium forcefully contracts, theblood pressure exerted on the valve's proximal side (the side closest tothe heart) may be greater than the pressure on the distal side(downstream) of the closed valve. The valve may passively function toprovide unidirectional blood flow.

In some variations, the valves may comprise three leaflets, which may beattached to the support structure in a triangular configuration. Thistriangular configuration may simulate the angled attachment of thenative leaflet and allow for anatomical draping of the tissue. In thenative valve this creates an anatomical structure between leaflets,known as the inter-leaflet trigone. Because the anatomical inter-leaflettrigone is believed to offer structural integrity and durability to thenative leaflets in humans, it is advantageous to simulate this structurein a prosthetic valve.

FIG. 13 is a perspective view of a tissue valve mounted to the supportstructure of FIG. 1A. As shown, a stented valve 120 may include aprosthetic tissue valve 121 attached to a support structure 10, such asthat described above.

The tissue valve 121 may include three pliable semi-circular leaflets121 a, 121 b, 121 c, which can be derived from biocompatible materialsas noted above. Adjacent leaflets may be attached in pairs tocommissures 123 x, 123 y, 123 z on the support structure 10. Inparticular, the commissures 123 x, 123 y, 123 z correspond tospaced-apart distal anchor points 13 x, 13 y, 13 z on the supportstructure 10. In an 18-strut stent, the commissures may be attached thestructure 10 via corresponding fasteners 25 at every third distal anchorpoint.

From the commissures, the leaflet sides may be connected to the adjacentdiagonal struts. That is, the sides of the first leaflet 121 a may besutured to the struts 11-Xa and 11-Za, respectively; the sides of thesecond leaflet 121 b may be sutured to the struts 11-Xb and 11-Yb,respectively; and the sides of the third leaflet 121 c may be sutured tothe struts 11-Yc and 11-Zc, respectively. Those sutures may end at thescissor articulated joints on the diagonal struts.

In the configuration shown, neighboring struts 11 may be attached to oneanother in a manner that creates multiple arches 128 at the ends of thestent. Posts for leaflet attachment, or commissures, may be formed byattaching a corresponding leaflet to each of the struts that define asuitable arch 128 x, 128 y, 128 z. In the configuration shown, there maybe three leaflets 121 a, 121 b, 121 c, each of which is attached to astrut along two of its opposing borders. The commissures may be formedby three equidistant arches 128 x, 128 y, 128 z in the stent.

The angled orientation of a strut in relationship to its neighboringstrut may permit the leaflets 121 a, 121 b, 121 c to be attached to thestent in a triangular configuration. This triangular configurationsimulates the angled attachment of the native aortic leaflet. In thenative valve this creates an anatomical structure between leaflets,known as the inter-leaflet trigone. Because the anatomical inter-leaflettrigone is believed to offer structural integrity and durability to thenative aortic leaflets in humans, it may be advantageous to simulatethis structure in a prosthetic valve.

One method of attachment of the leaflets to the struts is to sandwichthe leaflet between a multi-ply strut. The multiple layers may then beheld together by sutures, or the attachment may be sutureless.Sandwiching the leaflets between the struts may help to dissipate theforces on leaflets and prevent the tearing of sutures through theleaflets. The remaining side of each leaflet 121 a, 121 b, 121 c may besutured annularly across the intermediate strut members as shown by aleaflet seam.

FIG. 14 is a perspective view of a tissue valve mounted to the supportstructure of FIG. 6A. As shown, a stented valve 2800 may include aprosthetic tissue valve 121, as described above, to a support structure2510, as described above. Adjacent leaflets may be attached in pairs tocommissures 123 x, 123 y, 123 z on support structure 2510, whichcorrespond to the distal articulated joints 2515 located at the distalends of commissure strut members 2519.

From the commissures, the leaflet sides may be connected to the adjacentstruts. That is, the sides of the first leaflet 121 a may be sutured tothe struts 2511 a-1, 2519 a-1, 2511 a-2, 2519 a-2; the sides of thesecond leaflet 121 b may be sutured to the struts 2511 b-1, 2519 b-1,2511 b-2, 2519 b-2; and the sides of the third leaflet 121 c may besutured to the struts 2511 c-1, 2519 c-1, 2511 c-2, 2519 c-2. Thosesutures end at the scissor articulated joints 2515 on the longitudinalstruts 2511.

Like the attachment of leaflets to support structure 10 shown in FIG.13, the angled orientation of a strut in relationship to its neighboringstrut may enable the leaflets 121 a, 121 b, 121 c to be attached to thestent in a triangular configuration, as described in more detail above.

The tissue valve mounted to support structure shown in FIG. 6A may alsobe modified to sandwich the leaflets between multi-ply struts, and todrape the open spaces between the struts with a biocompatible skirt, asdescribed in more detail below.

In another embodiment, the tissue valve 121 may be mounted to thesupport structure 2510 in a secure, sutureless manner. Leaflets 121 a,121 b, 121 c can be suturelessly attached at the distal tip ofcommissures 123 x, 123 y, 123 z, and along the distal portion of struts2511. In some variations, the leaflets 121 a, 121 b, 121 c can also besuturelessly attached along struts 2519. More particularly, the sides ofleaflet 121 a may be suturelessly attached to the struts 2511 a-1, 2511a-2; the sides of leaflet 121 b may be suturelessly attached to thestruts 2511 b-1, 2511 b-2; and the sides of leaflet 121 c may besuturelessly attached to the struts 2511 c-1, 2511 c-2. In somevariations, the sides of leaflet 121 a can be suturelessly attached tothe struts 2919 a-1, 2519 a-2; the sides of leaflet 121 b can besuturelessly attached to the struts 2519 b-1, 2519 b-2; and the sides ofleaflet 121 c can be suturelessly attached to the struts 2519 c-1, 2519c-2.

The sutureless attachments may be formed by draping the leaflets overthe distal tips of commissures 123 x, 123 y, 123 z; sandwiching theleaflets between struts at articulated joints; or sandwiching theleaflets between multi-ply struts. More particularly, the sides ofleaflet 121 a can be sandwiched between the commissure strut 2519 c-1and commissure strut 2519 a-2 at the articulated joint at distal tip ofcommissure 123 z; sandwiched between commissure strut 2519 a-2 andlongitudinal strut 2511 a-2 at the connecting articulated joint;sandwiched between longitudinal strut 2511 a-2 and the rotatablyattached longitudinal strut 2511 at the middle articulated joint 2515;sandwiched between commissure strut 2519 a-1 and commissure strut 2519b-2 at the articulated joint at distal tip of commissure 123 x;sandwiched between commissure strut 2519 a-1 and longitudinal strut 2511a-1 at the connecting articulated joint; and sandwiched betweenlongitudinal strut 2511 a-1 and the rotatably attached longitudinalstrut 2511 at the middle articulated joint 2515. The rivets 2525 atthese articulated joints may pass through the leaflet 121 a.

The sides of leaflet 121 b can be sandwiched between the commissurestrut 2519 a-1 and commissure strut 2519 b-2 at the articulated joint atdistal tip of commissure 123 x; sandwiched between commissure strut 2519b-2 and longitudinal strut 2511 b-2 at the connecting articulated joint;sandwiched between longitudinal strut 2511 b-2 and the rotatablyattached longitudinal strut 2511 at the middle articulated joint 2515;sandwiched between commissure strut 2519 b-1 and commissure strut 2519c-2 at the articulated joint at distal tip of commissure 123 y;sandwiched between commissure strut 2519 b-1 and longitudinal strut 2511b-1 at the connecting articulated joint; and sandwiched betweenlongitudinal strut 2511 b-1 and the rotatably attached longitudinalstrut 2511 at the middle articulated joint 2515. The rivets 2525 atthese articulated joints may pass through the leaflet 121 b.

The sides of leaflet 121 c can be sandwiched between the commissurestrut 2519 b-1 and commissure strut 2519 c-2 at the articulated joint atdistal tip of commissure 123 y; sandwiched between commissure strut 2519c-2 and longitudinal strut 2511 c-2 at the connecting articulated joint;sandwiched between longitudinal strut 2511 c-2 and the rotatablyattached longitudinal strut 2511 at the middle articulated joint 2515;sandwiched between commissure strut 2519 c-1 and commissure strut 2519a-2 at the articulated joint at distal tip of commissure 123 z;sandwiched between commissure strut 2519 c-1 and longitudinal strut 2511c-1 at the connecting articulated joint; and sandwiched betweenlongitudinal strut 2511 c-1 and the rotatably attached longitudinalstrut 2511 at the middle articulated joint 2515. The rivets 2525 atthese articulated joints may pass through the leaflet 121 c.

In another embodiment, struts 2511 a-1, 2511 a-2, 2511 a-3, 2511 b-1,2511 b-2, 2511 b-3, 2511 c-1, 2511 c-2, 2511 c-3, 2519 a-1, 2519 a-2,2519 a-3, 2519 b-1, 2519 b-2, 2519 b-3, 2519 c-1, 2519 c-2, 2519 c-3 aremulti-ply struts, and the leaflets 121 a, 121 b, 121 c are sandwichedbetween the two or more layers of the struts. More particularly, oneside of leaflet 121 a may be sandwiched within the multi-ply strutmaking up commissure strut 2519 a-1 and the multi-ply strut making upthe distal portion of longitudinal strut 2511 a-1, and the other side ofleaflet 121 a may be sandwiched within the multi-ply strut making upcommissure strut 2519 a-1 and the multi-ply strut making up the distalportion of longitudinal strut 2511 a-2. One side of leaflet 121 b may besandwiched within the multi-ply strut making up commissure strut 2519b-1 and the multi-ply strut making up the distal portion of longitudinalstrut 2511 b-1, and the other side of leaflet 121 b may be sandwichedwithin the multi-ply strut making up commissure strut 2519 b-1 and themulti-ply strut making up the distal portion of longitudinal strut 2511b-2. One side of leaflet 121 c may be sandwiched within the multi-plystrut making up commissure strut 2519 c-1 and the multi-ply strut makingup the distal portion of longitudinal strut 2511 c-1, and the other sideof leaflet 121 c may be sandwiched within the multi-ply strut making upcommissure strut 2519 c-1 and the multi-ply strut making up the distalportion of longitudinal strut 2511 c-2.

In order to facilitate secure, suture-free leaflet attachment duringfabrication through sandwiching of the leaflets between the struts, theleaflets 121 a, 121 b, 121 c may comprise a shape as shown in FIG. 15having a central region 3401 having a semicircular or paraboloid shape,with two rectangular regions extending from each side of the centralregion 3401. The upper rectangular regions 3403 may be sandwiched withinmulti-ply struts making up commissure struts 2519, and the lowerrectangular regions 3405 may be sandwiched within multi-ply strutsmaking up longitudinal struts 2511. After the upper regions 3403 andlower regions 3405 are sandwiched between the struts, the outer portionsof the regions 3403, 3405 can be removed (e.g. by being cut off),leaving the central region 3401 suturelessly attached to the supportstructure 2510.

In other embodiments, tissue valves may be mounted to the other supportstructures described herein (e.g., support structures 10, 10′, 2510,2710, 3910, 3810, 4610) in the sutureless manner described above.

Skirts

In some variations, the support structures described here may haveskirts. The skirt may function to reduce or eliminate leakage around thevalve, or “paravalvular leak,” and in particular, may have increasedsealing when greater pressure is applied to the skirt. The skirt maycomprise a thin layer of material that lines all or a portion of thestructure. The material may be, but is not limited to, pericardialtissue, polyester, PTFE, or other material or combinations of materialssuitable for accepting tissue in growth, including chemically treatedmaterials to promote tissue growth or inhibit infection.

In the variation shown in FIG. 13, the remaining open spaces between thestruts after attachment of the valve leaflets can be draped by abiocompatible skirt 125 to help seal the valve against the implant siteand thus limit paravalvular leakage. As shown, the skirt 125 may beshaped to cover those portions of the stent below and between the valveleaflets.

In more detail, the skirt 125 at the base of the valve may be a thinlayer of material that lines the stent wall. To that end, there are anumber of ways to attach the skirt material layer to the stent. Theskirt layer may be on the inside or the outside of the stent; it mayoccupy the lower portion of the stent, the upper portion of the stent,or the lower and upper portion of the stent; it may occupy the areabetween the struts that define the commissure posts; it may becontinuous with the leaflet material; it may be sutured to the struts ora multitude of sites; and/or it may be secured to the lower portion ofthe stent, and pulled or pushed up to cover the outside of the stentduring the deployment in the body. The above list is not necessarilylimiting as those of ordinary skill in the art may recognize alternativedraping techniques for specific applications.

Method of Fabrication

The support structures described herein, including the attachment ofvalve leaflets and skirts, may be fabricated via a sutureless assemblymethod. As such, the fabrication method may avoid the labor-intensivemanual sewing generally involved in the fabrication of prosthetic valvereplacements. However, it should be appreciated that the fabricationmethod need not be sutureless. In some variations, the assembly methodmay be automated. The fabrication method may be used to fabricate asupport structure (e.g., an endoluminal support structure or a valvesupport structure) with or without an attached valve and/or skirt. Insome variations, the fabrication method may be used to separatelyfabricate a valve support structure with an attached valve and skirt,and an endoluminal support structure with an attached skirt, and thenthese two support structures may be connected. In other variations, thefabrication method may be used to simultaneously fabricate the valvesupport component and the endoluminal support component.

In general, the fabrication method described herein comprises connectingthe strut members, and any valve leaflets and/or skirts, in to aflattened chain. The flattened chain may then be shaped into the desiredshape (e.g., a cylindrical shape).

In some variations, this fabrication method may allow the components ofthe support structure to be arranged in a fixed configuration on aseparate support structure before being secured together. The flattenedchain may be fabricated by layering the strut members, and any valveleaflets and/or skirts and then securing them together. The valveleaflets and/or skirt may be sandwiched between the strut members,securing them in place without the use of sutures. The components maythus be layered in the order in which they will be in the final supportstructure. In some variations, the components may be layered from theinner-most components to the outer-most components. In other variations,the components may be layered from the outer-most components to theinner-most components.

The fabrication method may use one or more plates and/or alignmentguides to assist with alignment of the components. In general, one platemay be placed below the components, for the components to rest upon asthey are layered. This plate may also comprise openings through whichalignment guides may be placed, or alternatively, the plate may havepermanently attached alignment guides. The alignment guides may comprisepins, which may be configured to fit through orifices in the strutmembers, valve leaflets, and skirt material. The strut members, valveleaflets, and skirt material may thus be held in alignment by thealignment guides. A second plate may be placed above the componentsafter they are layered. Together, the two plates may allow thecomponents to be removed from the alignment guides after they arelayered, while maintaining their configuration, by applying compressiveforce to hold the components together.

After the components are layered, they may be secured together bysecuring elements (e.g., eyelets or rivets). In some variations, thesecuring elements may comprise openings through which the alignmentguides may be placed, and the securing elements may be layered with thestrut members, valve leaflets, and skirt material between the twoplates. For example, in variations in which the securing elementscomprise eyelets or rivets comprising a flange, the eyelets or rivetsmay be placed on the alignment guides above the first plate and beforethe bottom-most strut member. The flange may thus be sandwiched betweenthe first plate and the bottom-most strut member. The eyelet or rivetmay extend through the other components as they are layered onto thestrut member, and the top side of the eyelet or rivet may be swagedafter the layering is completed in order to secure the componentstogether. In other variations, the eyelets or rivets may be layeredafter the other components. In variations in which a valve leaflet orskirt material is sandwiched between the strut members, the compressiveforce from the strut members on the valve leaflet or skirt once thecomponents are secured together may hold the valve leaflet or skirt inplace without the need for sutures, although in some variations suturesmay also be used.

An example of the fabrication method as applied to the valve supportstructure is shown in FIGS. 16A-16W. FIG. 16A shows a perspective viewof an alignment plate 3610. The alignment plate 3610 may be configuredparticularly for the fabrication of the support structure 4610. Thealignment plate 3610 may comprise an opening 3620 corresponding to thelocation of each orifice 4613 of the strut members of support structure4610 when in a flattened configuration. In other variations, thealignment plate 3610 may comprise fewer openings, however. For example,the alignment plate 3610 may comprise openings corresponding to thelocation of each articulated joint of the support structure 4610. Inother variations, the alignment plate 3610 may comprise fewer openings,including no openings. The alignment plate 3610 may also comprisemarkings 3625, which may indicate the locations at which strut memberswill be placed onto the alignment plate 3610 during the fabricationprocess, although it should be understood that the markings 3625 are notrequired.

Alignment guides (e.g., pins 3630) may be placed through the openings3620, as shown in FIG. 16B. As shown there, not all openings 3620 mayhave pins 3630 placed through them. Instead, the pins 3630 may be placedthrough openings 3620 on the distal side of the support structure,through the openings 3620 corresponding to the configuration of orifices4613 of the commissure strut members 4619 of the support structure 4619and the orifices 4613 of the longitudinal strut members 4611 forming acontiguous line of openings with those of the corresponding to thecommissure strut members. In other variations, pins 3630 may be placedinto more or all of the openings 3620 of the plate 3610. For example,pins 3630 may be placed through each opening 3620 of the plate 3610corresponding to the location of articulated joints of support structure4610. A schematic of the flattened chain and openings is shown in FIG.16C, with the openings through which pins may be placed shaded. In othervariations, pins 3630 may be placed into fewer openings 3620 of theplate 3610, including no openings. It should also be appreciated that insome variations, the alignment guides may be attached or integral to thealignment plate. For example, the alignment plate may not compriseopenings, but may instead comprise alignment guides permanentlyextending from the same locations at which alignment guides could beplaced through openings in the alignment plate described above.

The alignment plate 3610 with loaded pins 3630 may be placed on top of abase frame 3640 and clamped in place, as shown in FIGS. 16D-16F. Thebase frame 3640 may comprise a top layer 3640-1 and a bottom later3640-2. In some variations, the base frame may comprise a component orcomponents to help secure the alignment plate in place. Such a variationof a base frame 3690 is shown in FIG. 16X. In the variation shown there,the base frame 3690 may comprise rotating clamps 3695. The rotatingclamps 3695 may be rotated over the alignment plate 3610 once it isplaced on the base frame, which may hold the alignment plate 3610 inplace.

Eyelets or rivets may then be loaded onto a subset of the pins 3630. Theeyelets or rivets may be loaded onto the pins 3630 corresponding tolocations of the articulated joints of support structure 4610. A sidecut-away view of an example of an eyelet 3710 is shown in FIG. 17F. Asshown, the eyelets or rivets may comprise a larger portion 3712 and asmaller portion 3714, where the larger portion 3712 of the eyelet orrivet (i.e., the flange) is larger in at least one cross-sectionaldimension (i.e., perpendicular to longitudinal axis 3716) than thesmaller portion 3714 of the eyelets or rivets. The eyelet or rivet maybe loaded onto the pins such that the eyelet or rivet flange residesagainst to the plate 3610, and the smaller portion 3714 faces upwards,with the longitudinal axis 3716 perpendicular to the alignment plate3610. The dimensions of the flange 3712 may be such that it may not passthrough the openings 3620 of the plate 3610. The dimensions of theflange 3712 may also be such that it may not pass through the orifices4613 of the strut members of the support structure 4610, described inmore detail below, while the dimensions of the smaller portion 3717 maybe such that it may pass through the orifices 4613 of the strut membersof the support structure 4610. Thus, when the strut members are placedon the pins 3630, the narrower portion of the eyelets or rivets may passthrough the orifices 4613, sandwiching the flange between the plate 3610and the strut members and holding it in a configuration where thelongitudinal axis 3716 is perpendicular to the alignment plate 3610. Theeyelets or rivets may remain sandwiched between the plate 3610 and thestrut members after the plates and strut members are removed from thepins 3630 (described below). The smaller portion 3714 may have a height(i.e., dimension along the longitudinal axis 3716) sufficient to passfully through all of the components layered into the pins 3630 duringthe fabrication process (e.g., the strut members, skirt material, andvalve leaflets, as described below) when the flange is sandwiched asdescribed, such that the smaller portion 3714 may be swaged after thecomponents are layered. It should be appreciated that in somevariations, an eyelet or rivet may not be placed at each locationcorresponding to an articulating joint of the support structure. Forexample, no eyelet or rivet may be placed at articulated joints at whichthe support structure may be intended to be connected to another supportstructure (e.g., at articulated joints at which support structure 4610is intended to be connected to an endoluminal support structure, such assupport structure 3810 or 3910).

A subset of the longitudinal strut members 4611 may then be placed onthe pins 3630, as shown in FIG. 16G. This subset may correspond to theoutermost set of strut members of support structure 4610. A schematic ofthe flattened chain and openings is shown in FIG. 16H, with the strutmembers placed onto the shaded areas. The numbers indicate the order inwhich the strut members may be placed onto the pins. The longitudinalstrut members 4611 may be mounted on the pins 3630 by placing the pins3630 through orifices 4613 of the longitudinal strut members 4611. Thesmaller portion 3714 of the eyelets may fit through the orifices 4613,while the wider diameter portion of the eyelets may not. The subset ofthe longitudinal strut members 4611 mounted on the pins 3630 maycomprise six longitudinal strut members 4611. The longitudinal strutmembers mounted on the pins 3630 in this step may all be parallel toeach other and may not overlap with each other. More specifically, thelongitudinal strut members 4611 first mounted on the pins 3630 maycomprise the three outer longitudinal strut members 4611-2 and the threeouter longitudinal strut members 4611-4. The three outer longitudinalstrut members 4611-4 may be first placed on the pins 3630. While thevariation shown in FIG. 16H indicates that the three outer longitudinalstrut members 4611-4 may be placed in order from left to right, in othervariations, they may be placed in any other order, such as but notlimited to right to left. The outer longitudinal strut members 4611-2may then be placed onto the pins 3630. While the variation shown in FIG.16H indicates that the three outer longitudinal strut members 4611-4 maybe placed in order from left to right, in other variations, they may beplaced in any other order, such as but not limited to right to left. Theouter longitudinal strut members 4611-2 may be placed onto the pins 3630in a double layer (i.e., a pair of struts sitting on top of each other),as opposed to the single layer of outer longitudinal strut members4611-4. The double layer may provide greater flexibility to these areasof the support structure, allowing the support structure to flex tomimic a PERIMOUNT open surgical valve. In so placing the longitudinalstrut members 4611 on the pins 3630 as described, a pin may be placedthrough each orifice 4613 of the longitudinal strut members 4611-2 and4611-4. In other variations a pin may be placed through fewer than eachorifice of the longitudinal strut members. In some variations, thelongitudinal strut members 4611-4 may have a thickness of 0.008, and thelongitudinal strut members 4611-2 may individually have a thickness of0.005. One configuration of longitudinal strut members 4611-4 is shownin more detail in FIG. 17B. One configuration of longitudinal strutmembers 4611-2 is shown in more detail in FIG. 17C.

The commissure strut members 4619 may then be placed on the pins 3630,as shown in FIG. 161. A schematic of the flattened chain and openings isshown in FIG. 16J, with the strut members placed onto the shaded areas.The numbers indicate the order in which the strut members may be placedonto the pins. More specifically, the three commissure strut members4619-2 may be first placed on the pins 3630, which may be done from leftto right as indicated. The three commissure strut members 4619-1 maythen be placed on the pins 3630, which also may be done from left toright. However, it should be appreciated that both sets of thecommissure strut members 4619 may be placed onto the pins in otherorders, such as but not limited to right to left. A pin may be placedthrough each orifice 4613 of the commissure strut members 4619. In othervariations a pin may be placed through fewer than each orifice of thelongitudinal strut members. All of the commissure strut members 4619 mayhave a thickness of 0.005 and may be placed onto the pins 3630 in asingle layer. One configuration of the commissure strut members 4619 isshown in more detail in FIG. 17D.

The remaining longitudinal strut members 4611 of the support structure4610 may then be placed on the pins 3630, as shown in FIG. 16K. Aschematic of the flattened chain and openings is shown in FIG. 16L, withthe strut members placed onto the shaded areas. The numbers indicate theorder in which the strut members may be placed onto the pins. Theseremaining longitudinal strut members 4611 may comprise six parallellongitudinal strut members 4611—more specifically, three innerlongitudinal strut members 4611-1 and three inner longitudinal strutmembers 4611-3. The three inner longitudinal strut members 4611-1 may befirst placed on the pins 3630. While the variation shown in FIG. 16Lindicates that the three inner longitudinal strut members 4611-1 may beplaced in order from left to right, in other variations, they may beplaced in any other order, such as but not limited to right to left. Thethree inner longitudinal strut members 4611-3 may then be placed intothe pins 3630. While the variation shown in FIG. 16L indicates that thethree inner longitudinal strut members 4611-3 may be placed in orderfrom left to right, in other variations, they may be placed in any otherorder, such as but not limited to right to left. The three innerlongitudinal strut members 4611-3 may be placed onto the pins 3630 in adouble layer (i.e., a pair of struts sitting on top of each other), asopposed to the single layer of outer longitudinal strut members 4611-1.The double layer may provide greater flexibility to these areas of thesupport structure, allowing the support structure to flex to mimic aPERIMOUNT open surgical valve. In contrast to the placement of outerlongitudinal strut members 4611-2, 4611-4, a pin may not be placedthrough each orifice of the inner longitudinal strut members 4611-1,4611-3. A pin may only be placed through the distal-most orifice 4613 ofeach inner longitudinal strut member 4611-1, 4611-3, at the locationcorresponding to the articulated joints 4615-2 and 4615-3. In somevariations, the longitudinal strut members 4611-1 may have a thicknessof 0.008, and the longitudinal strut members 4611-3 may have a thicknessof 0.005. One configuration of the longitudinal strut members 4611-1 isshown in more detail in FIG. 17B. One configuration of the longitudinalstrut members 4611-3 is shown in more detail in FIG. 17C.

The skirt material 3670 may then be placed over the pins 3630, as shownin FIG. 16M. In some variations, the skirt material 3670 may compriseDacron. Before being lowered onto the pins 3630, the skirt material 3670may be stretched taut using an embroidery-hoop like device 3680 that maysandwich the skirt material 3670 between two hoops while being placedover the pins 3630. In variations in which the skirt material is woven,the fibers may be oriented diagonally relative to the horizontal planeof the frame (i.e., along the bias). Orienting the skirt material inthis way may allow the material to stretch to accommodate the adjustablediameter of the assembled support structure. In some variations in whichthe material is woven, the pins 3630 may fit through the naturalopenings between the woven fibers. In other variations, the skirtmaterial may comprise openings configured to receive the pins 3630through them. In yet other variations, the pins 3630 may be configuredto pierce or cut the skirt material (e.g., by comprising a sharpened orpointed end) in order to allow the pins 3630 to be placed through theskirt material.

Three valve leaflets 4621 a, 4621 b, 4621 c, shown in FIG. 16N, may thenbe placed onto the pins 3630, as shown in FIG. 16O. The valve leafletsmay comprise a substantially rounded triangular shape, as shown. In somevariations, the valve leaflets may comprise tabs 4623 on either side toassist with placement of the leaflets onto the pins. In some variations,the valve leaflets 4621 may comprise openings 4626 configured to receivethe pins 3630 through them. In other variations, the valve leaflets 4621may not comprise openings, but the pins 3630 may be configured to pierceor cut the valve leaflets 4621 (e.g., by comprising a sharpened orpointed end) in order to allow the pins 3630 to be placed through thevalve leaflets 4621. Once placed onto the pins 3630, the valve leafletsmay sit flat against the skirt material, as shown in FIG. 16O.

More strut members may then be placed on the pins 3630 over the valveleaflets. The strut members may be placed in locations corresponding tothe edges of the valve leaflets 4621, which may also correspond to thelocations of the commissure strut members and a subset of longitudinalstrut members of support structure 4610. The strut members may thussandwich the edges of the valve leaflets between them and the previouslyplaced strut members (with the skirt material intervening). A schematicof the flattened chain and openings is shown in FIG. 16P, with the strutmembers placed onto the shaded areas. The numbers indicate the order inwhich the strut members may be placed onto the pins. As indicated, threestrut members corresponding to the location of commissure strut members4619-2 may first be placed on the pins 3630.

While the variation shown in FIG. 16P indicates that the three outerlongitudinal strut members 4619-2 may be placed in order from left toright, in other variations, they may be placed in any other order, suchas but not limited to right to left. Three strut members correspondingto commissure strut members 4619-1 may then be placed onto the pins3630, which may also be done from left to right, or in other variationsmay be done in other orders, such as but not limited to right to left.Three strut members corresponding to outer longitudinal strut members4611-4 may then be placed onto the pins 3630, which may also be donefrom left to right, or in other variations may be done in other order,such as but not limited to right to left. Three strut memberscorresponding to inner longitudinal strut members 4611-1 may then beplaced onto the pins 3630 in a single layer, which may also be done fromleft to right, or in other variations may be done in other order, suchas but not limited to right to left. In so placing the strut membersonto the pins 3630 as described, a pin may be placed through eachorifice 4613 of the struts corresponding to the longitudinal strutmembers 4611 and commissure strut members 4619. In other variations apin may be placed through fewer than each orifice of the longitudinalstrut members. These struts may have a thickness of 0.005. Oneconfiguration of the strut members corresponding to commissure strutmembers 4619-1, 4619-2 is shown in more detail in FIG. 17D. Oneconfiguration of the strut members corresponding to longitudinal strutmembers 4611-1, 4611-4 is shown in more detail in FIG. 17A.

Coaptation strut members 4651 may then be placed on the pins 3630, asshown in FIG. 16Q. A schematic of the flattened chain and openings isshown in FIG. 16R, with the strut members placed onto the shaded areas.The numbers indicate the order in which the strut members may be placedonto the pins. It should be noted that the skirt material and valveleaflets are not shown in FIG. 16Q in order to reveal the underlyingstrut members. The three coaptation strut members 4651-2 may be firstplaced on the pins 3630, which may be done from left to right asindicated. Three coaptation strut members 4651-1 may then be placed onthe pins 3630, which also may be done from left to right. The coaptationstrut members 4651 may have a thickness of 0.005 and may be placed in asingle layer. The coaptation strut members 4651 may comprise a wire,which in some variations may comprise a shape memory material, such asNitinol. One configuration of the coaptation strut members 4651-1,4651-2 is shown in more detail in FIG. 17E. However, it should beappreciated that the coaptation strut members 4651 may have otherconfigurations; for example, they may have a longer length, which mayallow them to follow the entire length of the valve leaflet when thecoaptation strut members 4651 are rotated over the leaflets, asdescribed in more detail below. Additionally or alternatively, thecoaptation strut members 4651 may comprise a single element or multipleelements. One configuration of the coaptation strut members 4651-1,4651-2 is shown in more detail in FIG. 17E. A pin may be placed onlythrough one orifice 4613 of each of the coaptation strut members 4651;this may allow the coaptation strut members 4651 to be rotated duringthe fabrication process, as described in more detail below. Morespecifically, each pair of coaptation strut members 4651-1, 4651-2 maybe placed over the pin corresponding to the location of the articulatedjoint 4615-4 of support structure 4610.

A cover plate 3650 may then be placed over the pins 3630, as shown inFIGS. 16S-16T. The cover plate may but need not comprise openings 3660corresponding to the location of each orifice 4613 of the strut membersof support structure 4610. It should be appreciated that the cover platemay comprise fewer openings; for example, the cover plate may compriseopenings only corresponding to the placement of pins 3630, as describedabove, or openings only corresponding to the placement of eyelets orrivets, as described above. Once placed over the pins 3630, each pin3630 may go through an opening 3660 of the cover plate 3650 invariations having an opening corresponding to each pin. The openings3660 of the cover plate 3650 may be larger than the openings 3620 of thealignment plate to allow access for a swaging tool, as described in moredetail below.

The alignment plate 3610 and the cover plate 3650, and the eyelets,strut members, skirt material, and valve leaflets located in between thetwo plates, may then be removed from the base frame 3640 by sliding themup and off of the pins 3630, as shown in FIG. 16U. Compressive force maybe applied to the alignment plate 3610 and the cover plate 3650 whileremoving them from the pins 3630, which may hold the eyelets, strutmembers, skirt material, and valve leaflets in place as and after theyare removed from the pins 3630.

The eyelets may then be swaged. In some variations, the swaging may bedone using a manual swaging tool. In other variations, a benchtopswaging instrument may be used. The openings 3660 in the cover plate3650 may be large enough to allow the swaging tool to access eacheyelet. FIG. 17G illustrates a side view of an eyelet after beingswaged. As shown, after being swaged, the end of the smaller portion3714 may be bent outward. After being bent outward, at least onedimension of the smaller portion 3714 of the eyelet or rivet may belarge enough that it may not pass through the openings 4613 of the strutmembers of the support structure 4610. The layered strut members, valveleaflets, and skirt material may thus be held between the flange 3712 ofthe eyelet and the outwardly bent end of the smaller portion 3714,securing them together. However, the dimensions of the smaller portion3714 of the eyelet or rivet once bent outwardly may be small enough tofit through the openings 3660 of the cover plate 3650, such that thecover plate 3650 may be removed from the layered components afterswaging.

After the eyelets or rivets are swaged to hold the layered strutmembers, valve leaflets, and skirt material together, the alignmentplate 3610 and cover plate 3650 may be removed. The flattened chain maythen be shaped into the final shape of the support structure 4610, i.e.,into a tubular shape. The ends of the flattened chain may be interlinkedto hold the flattened chain into the final shape, e.g., by securing theends together with eyelets, which may then be swaged.

The coaptation strut members 4651 may then be moved from their initialposition, as shown in FIG. 16Q, into a final position, shown in FIG.16V. In the initial position, the coaptation strut members 4651 mayextend in part distally to the articulated joint 4615-4. In the finalposition, the coaptation strut member 4651 may extend in part proximallyto the articulated joint 4615-4. The coaptation strut members 4651 maybe rotated proximally and away from each other about the articulatedjoint 4615-4 to be moved from the initial position to the finalposition. As the coaptation strut members 4651 are rotated proximallyand away from each other, they may come into contact with the valveleaflets 4621 a, 4621 b, 4621 c and may bend the outer distal ends ofeach leaflet proximally, biasing each valve leaflet 4621, 4621 b, 4621 cinto a closed position, as shown in FIG. 16V. In some variations, thefree ends of the coaptation strut members may then be secured to theunderlying commissure struts by eyelets. The eyelets may be swaged usinga hand tool. This may sandwich the valve material between the commissurestrut members 4619 and the coaptation strut members 4651 biased in theclosed position. It should be appreciated, however, that the free endsof the coaptation strut members need not be secured to the underlyingcommissure strut members by eyelets. In some variations, the free endsof the coaptation strut members may be held in place via other methods,such as but not limited to friction.

The excess skirt material 3670 (i.e., the skirt material extendingdistally to the support structure 4610) may then be trimmed off,resulting in the support structure with valve and skirt shown in FIG.16W.

It should be appreciated that the method of fabrication may be performedin the reverse order, beginning with coaptation strut members 4651 andending with the outermost struts. It should also be appreciated thatcertain steps may be performed in different orders; for example, eachgroup of strut members placed onto the pins 3630 may be placed onto thepins from right to left.

A similar method may also be used to fabricate an endoluminal supportstructure, such as the support structure 3910 of FIG. 5. Oncefabricated, the valve support structure fabricated above may beconnected to the endoluminal support structure, as described in moredetail below. The endoluminal support structure may be fabricated with askirt by sandwiching the skirt material between two sets of strutmembers. In some variations, the two sets of strut members may be thesame, while in other variations, the two sets of strut members may bedifferent. In one variation of the method, the support structure 3910may be fabricated using an alignment plate 4410 such as the one shown inFIG. 18A. The alignment plate 4410 may comprise an opening 4420corresponding to the location of each orifice 3913 of the strut membersof support structure 3910 when in a flattened configuration. In othervariations, the alignment plate 4410 may comprise fewer openings,however. For example, the alignment plate 4410 may comprise openingscorresponding to the location of each articulated joint of the supportstructure 3910. In other variations, the alignment plate 4410 maycomprise fewer openings, including no openings. The alignment plate 4410may also comprise markings 4425, which may indicate the locations atwhich strut members will be placed onto the alignment plate 4410 duringthe fabrication process, although it should be understood that themarkings 4425 are not required.

Alignment guides (e.g., pins) may be placed through the openings 4420.Not all openings 4420 may have pins placed through them. Instead, thepins may be placed through openings 4420 through the openings 4420corresponding to the configuration of articulated joints of the supportstructure 3910. In other variations, pins may be placed into more or allof the openings 4420 of the plate 4410. For example, pins may be placedthrough each opening 4420 of the plate 4410. A schematic of theflattened chain and openings is shown in FIG. 18B, with the openingsthrough which pins may be placed shaded. In other variations, pins maybe placed into fewer openings 4420 of the plate 4410, including noopenings. It should also be appreciated that in some variations, thealignment guides may be attached or integral to the alignment plate. Forexample, the alignment plate may not comprise openings, but may insteadcomprise alignment guides permanently extending from the same locationsat which alignment guides could be placed through openings in thealignment plate described above.

The alignment plate 4410 with loaded pins may be placed on top of a baseframe and clamped in place as described above with respect to the valvesupport structure above. The same or a different base plate may be usedfor alignment plate 4410.

Eyelets or rivets may then be loaded onto the pins. In variations inwhich the pin locations include ones that do not correspond toarticulated joints of the support structure 3910, the eyelets or rivetsmay be loaded only onto pins corresponding to articulated joints of thesupport structure 3910. The eyelets may be the same or have similarfeatures as described above with respect to FIGS. 17F-17G. It should beappreciated that in some variations, an eyelet or rivet may not beplaced at each location corresponding to an articulating joint of thesupport structure. For example, no eyelet or rivet may be placed atarticulated joints at which the support structure may be intended to beconnected to another support structure (e.g., at articulated joints atwhich support structure 3910 is intended to be connected to valvesupport structure 4610).

A subset of the strut members 3911 may then be placed on the pins. Thissubset may correspond to the outermost set of strut members of supportstructure 3910. A schematic of the flattened chain and openings is shownin FIG. 18C, with the strut members placed onto the shaded areas. Thenumbers 1 through 6 indicate the order in which the strut members may beplaced onto the pins. The strut members 3911 may be mounted on the pinsby placing the pins through orifices 3913 of the strut members 3911. Thesmaller portion of the eyelets may fit through the orifices 3913, whilethe wider diameter portion of the eyelets may not. The subset of thelongitudinal strut members 3911 mounted on the pins may comprise thethree strut members 3911-2 and the three strut members 3911-4, asdescribed in more detail with respect to FIG. 5. The strut membersmounted on the pins in this step may all be parallel to each other andmay not overlap with each other. While the variation shown in FIG. 18Cindicates that the strut members may be placed in order from left toright, in other variations, they may be placed in any other order, suchas but not limited to right to left. In so placing the strut members3911 on the pins as described, a pin may be placed through each orifice3913 of the strut members 3911. In other variations a pin may be placedthrough fewer than each orifice of the longitudinal strut members.

The remaining strut members 3911 of the support structure 3910 may thenbe placed on the pins. A schematic of the flattened chain and openingsis shown in FIG. 18D, with the strut members placed onto the shadedareas. The numbers 1 through 6 indicate the order in which the strutmembers may be placed onto the pins. These remaining strut members 3911may comprise six parallel strut members 3911—more specifically, the sixinnermost strut members of support structure 3910. This may include thethree strut members 3911-1 and three strut members 3911-3. While thevariation shown in FIG. 18D indicates that the strut members may beplaced in order from left to right, in other variations, they may beplaced in any other order, such as but not limited to right to left. Inso placing the strut members 3911 on the pins as described, a pin may beplaced through each orifice 3913 of the strut members 3911.

Skirt material may then be placed over the pins. In some variations, theskirt material may comprise Dacron. Before being lowered onto the pins,the skirt material may be stretched taut using an embroidery-hoop likedevice that may sandwich the skirt material between two hoops whilebeing placed over the pins, as described in more detail above withrespect to FIG. 16M. In some variations in which the material is woven,the pins may fit through the natural openings between the woven fibers.In other variations, the skirt material may comprise openings configuredto receive the pins through them. In yet other variations, the pins maybe configured to pierce or cut the skirt material (e.g., by comprising asharpened or pointed end) in order to allow the pins to be placedthrough the skirt material.

More strut members may then be placed on the pins over the skirtmaterial. The strut members may sandwich the skirt material between themand the previously placed strut members. These strut members may in somevariations be at the same locations as the strut members located belowthe skirt material, but in other variations may be located at otherlocations. In variations in which these strut members overlap with eachother, the strut members may be placed in a particular order over theskirt material. For example, in some variations, six strut members maybe placed over the skirt material at locations that correspond to asubset of the locations of the strut members located below the skirtmaterial. A schematic of this example is shown in FIG. 18E, with threestrut members corresponding to the locations of strut members 3911-3first placed onto the pins, shown by the shaded areas. A second group ofthree strut member corresponding to the locations of strut members3911-4 may then be placed onto the pins, as indicated in FIG. 36F. Thenumbers 1 through 3 indicate the order in which the strut members may beplaced onto the pins. While the variation shown in FIG. 18E-18Findicates that the strut members may be placed in order from left toright, in other variations, they may be placed in any other order, suchas but not limited to right to left. It should also be appreciated thatthe skirt material may be sandwiched between the strut members shown inFIGS. 18C-18D and strut members having different configurations than thestrut members shown in FIGS. 18E-18F. For example, the strut membersplaced over the skirt material may comprise strut members correspondingto strut members 3911-1 and 3911-2 of support structure 3910.

A cover plate may then be placed over the pins. The cover plate may butneed not comprise openings corresponding to the location of each orifice3913 of the strut members of support structure 3910. It should beappreciated that the cover plate may comprise fewer openings; forexample, the cover plate may comprise openings only corresponding to theplacement of pins, as described above, or openings only corresponding tothe placement of eyelets or rivets, as described above. Once placed overthe pins, each pin may go through an opening of the cover plate invariations having an opening corresponding to each pin. The openings ofthe cover plate may be larger than the openings of the alignment plateto allow access for a swaging tool, as described in more detail below.

The alignment plate 4410 and the cover plate, and the eyelets, strutmembers, and skirt material located in between the two plates may thenbe removed from the base frame by sliding them up and off of the pins.Compressive force may be applied to the alignment plate 4410 and thecover plate while removing them from the pins, which may hold theeyelets, strut members, skirt material, and valve leaflets in place asand after they are removed from the pins. The eyelets may then beswaged, as described in more detail with respect to support structure3610 above. After the eyelets or rivets are swaged to hold the layeredstrut members and skirt material together, the alignment plate 4410 andcover plate may be removed. The flattened chain may then be shaped intothe final shape of the support structure 3910, i.e., into a tubularshape. The ends of the flattened chain may be interlinked to hold theflattened chain into the final shape, e.g., by securing the endstogether with eyelets, which may then be swaged. Once rolled into thefinal shape, an actuator may in some instances be attached to thesupport structure, in the manner described in more detail above. Inother variations, an actuator may be attached to the flattened chainbefore it is shaped into the final shape.

It should be appreciated that the method of fabrication may be performedin the reverse order, beginning with the innermost strut members andending with the outermost strut members. It should also be appreciatedthat certain steps may be performed in different orders; for example,each group of strut members placed onto the pins may be placed onto thepins from right to left.

Once fabricated, the valve support structure fabricated above may beconnected to the endoluminal support structure. It should also beappreciated that in some variations of the methods described herein, thevalve support structure and endoluminal support structure may befabricated simultaneously—that is, as a single flattened chain, whichmay then be rolled into a tubular structure. It should also beappreciated that the support structures described herein may befabricated in a similar method using three-dimensional printing. In somevariations, three-dimensional printing may be used to print theflattened chain of components described herein, either from outermost toinnermost, or from innermost to outermost, and then the chain may beshaped into a tubular structure. In other variations, three-dimensionalprinting may be used to print the strut members of the flattened chain,while the skirt and/or valve leaflets may be added separately during theprinting process. In yet other variations, three-dimensional printingmay be used to print the device in its final tubular form.

Similar methods may be used to fabricate other support structures. Forexample, a similar fabrication method may be used to fabricate a supportstructure such as the one shown schematically in a flattenedconfiguration FIG. 19A. To fabricate this support structure, a similaralignment plate may be used, but the openings and markings maycorrespond to those shown in FIG. 19A. That is, the alignment plate maycomprise an opening corresponding to the location of each orifice of thestrut members of support structure when in a flattened configuration. Inother variations, the alignment plate may comprise fewer openings,however. For example, the alignment plate may comprise openingscorresponding to the location of each articulated joint of the supportstructure. In other variations, the alignment plate may comprise feweropenings, including no openings. It should be understood that themarkings on the alignment plate are not required.

Alignment guides (e.g., pins) may be placed through the openings. Notall openings may have pins placed through them. Instead, the pins may beplaced through openings through the openings corresponding to theconfiguration of articulated joints of the support structure. In othervariations, pins may be placed into more or all of the openings of thealignment plate. For example, pins may be placed through each opening ofthe alignment plate. A schematic of the flattened chain and openings isshown in FIG. 19B, with the openings through which pins may be placedshaded. In other variations, pins may be placed into fewer openings ofthe alignment plate, including no openings. It should also beappreciated that in some variations, the alignment guides may beattached or integral to the alignment plate. For example, the alignmentplate may not comprise openings, but may instead comprise alignmentguides permanently extending from the same locations at which alignmentguides could be placed through openings in the alignment plate describedabove.

The alignment plate with loaded pins may be placed on top of a baseframe and clamped in place as described in more detail above withrespect to the valve support structure 4610.

Eyelets or rivets may then be loaded onto the pins. In variations inwhich the pin locations include ones that do not correspond toarticulated joints of the support structure, the eyelets or rivets maybe loaded only onto pins corresponding to articulated joints of thesupport structure. The eyelets may be the same or have similar featuresas described above with respect to FIGS. 17F-17G. It should beappreciated that in some variations, an eyelet or rivet may not beplaced at each location corresponding to an articulating joint of thesupport structure. For example, no eyelet or rivet may be placed atarticulated joints at which the support structure may be intended to beconnected to another support structure.

A subset of the strut members may then be placed on the pins. Thissubset may correspond to the outermost set of strut members of supportstructure. A schematic of the flattened chain and openings is shown inFIG. 19C, with the strut members placed onto the shaded areas. Thenumbers 1 through 5 indicate the order in which the strut members may beplaced onto the pins. The strut members may be mounted on the pins byplacing the pins through orifices of the strut members. The smallerportion of the eyelets may fit through the orifices, while the widerdiameter portion of the eyelets may not. The subset of the longitudinalstrut members mounted on the pins may comprise the five outermost strutmembers. The strut members mounted on the pins in this step may all beparallel to each other and may not overlap with each other. While thevariation shown in FIG. 19C indicates that the strut members may beplaced in order from left to right, in other variations, they may beplaced in any other order, such as but not limited to right to left. Inso placing the strut members on the pins as described, a pin may beplaced through each orifice of the strut members, or a pin may be placedthrough fewer (e.g., two) orifices of each strut member.

A second subset of the strut members of the support structure may thenbe placed on the pins. A schematic of the flattened chain and openingsis shown in FIG. 19D, with the strut members placed onto the shadedareas. The numbers 1 through 5 indicate the order in which the strutmembers may be placed onto the pins. These strut members may comprisefive parallel strut members. While the variation shown in FIG. 19Dindicates that the strut members may be placed in order from left toright, in other variations, they may be placed in any other order, suchas but not limited to right to left. In so placing the strut members onthe pins as described, a pin may be placed through each orifice of thestrut members, or a pin may be placed through fewer (e.g., two) orificesof each strut member.

A third subset of the strut members of the support structure may then beplaced on the pins. A schematic of the flattened chain and openings isshown in FIG. 19E, with the strut members placed onto the shaded areas.The numbers 1 through 5 indicate the order in which the strut membersmay be placed onto the pins. These strut members may comprise fiveparallel strut members. While the variation shown in FIG. 19E indicatesthat the strut members may be placed in order from left to right, inother variations, they may be placed in any other order, such as but notlimited to right to left. In so placing the strut members on the pins asdescribed, a pin may be placed through each orifice of the strutmembers, or a pin may be placed through fewer (e.g., two) orifices ofeach strut member.

A fourth subset of the strut members of the support structure may thenbe placed on the pins. A schematic of the flattened chain and openingsis shown in FIG. 19F, with the strut members placed onto the shadedareas. The numbers 1 through 5 indicate the order in which the strutmembers may be placed onto the pins. These strut members may comprisefive parallel strut members, and may comprise the innermost strutmembers. While the variation shown in FIG. 19F indicates that the strutmembers may be placed in order from left to right, in other variations,they may be placed in any other order, such as but not limited to rightto left. In so placing the strut members on the pins as described, a pinmay be placed through each orifice of the strut members, or a pin may beplaced through fewer (e.g., two) orifices of each strut member.

A cover plate may then be placed over the pins. The cover plate may butneed not comprise openings corresponding to the location of each orificeof the strut members of support structure. It should be appreciated thatthe cover plate may comprise fewer openings; for example, the coverplate may comprise openings only corresponding to the placement of pins,as described above, or openings only corresponding to the placement ofeyelets or rivets, as described above. Once placed over the pins, eachpin may go through an opening of the cover plate in variations having anopening corresponding to each pin. The openings of the cover plate maybe larger than the openings of the alignment plate to allow access for aswaging tool, as described in more detail below.

The alignment plate and the cover plate, and the eyelets and strutmembers located in between the two plates may then be removed from thebase frame by sliding them up and off of the pins. Compressive force maybe applied to the alignment plate and the cover plate while removingthem from the pins, which may hold the eyelets and strut members. Theeyelets may then be swaged, as described in more detail with respect tosupport structure 3610 above. After the eyelets or rivets are swaged tohold the layered strut members and skirt material together, thealignment plate and cover plate may be removed. The flattened chain maythen be shaped into the final shape of the support structure, i.e., intoa tubular shape. The ends of the flattened chain may be interlinked tohold the flattened chain into the final shape, e.g., by securing theends together with eyelets, which may then be swaged. Once rolled intothe final shape, an actuator may in some instances be attached to thesupport structure, in the manner described in more detail above. Inother variations, an actuator may be attached to the flattened chainbefore it is shaped into the final shape.

It should be appreciated that the method of fabrication may be performedin the reverse order. It should also be appreciated that certain stepsmay be performed in different orders; for example, each group of strutmembers placed onto the pins may be placed onto the pins from right toleft. It should also be appreciated that the method of fabrication maycomprise the addition of skirt material and/or valve leaflets, which maybe attached by being sandwiched between strut members, in a mannersimilar to that described above. It should also be appreciated that thesupport structure described herein may be fabricated in a similar methodusing three-dimensional printing. In some variations, three-dimensionalprinting may be used to print the flattened chain of componentsdescribed herein, either from outermost to innermost, or from innermostto outermost, and then the chain may be shaped into a tubular structure.In other variations, three-dimensional printing may be used to print thestrut members of the flattened chain, while the skirt and/or valveleaflets may be added separately during the printing process. In yetother variations, three-dimensional printing may be used to print thedevice in its final tubular form.

It should be appreciated that the support structures described hereinmay be fabricated using variations of the methods described above. Inanother variation, the support structure 4610 may also be fabricated byconnecting the strut members into a flattened chain by layering thestrut members and then securing them together. This may be facilitatedusing alignment guides. More specifically, the strut members may beconnected by placing the appropriate orifices 4613 of the strut membersonto alignment guides in an appropriate order. In one variation, thestrut members may be placed onto the alignment guides in an order fromouter-most to inner-most: the outer layer of longitudinal strut members(e.g. 4611-1, 4611-3) may first be placed onto the alignment guidesthrough orifices 4613; the inner layer of longitudinal strut members(e.g. 4611-2, 4611-4) may then be placed onto the alignment guidesthrough orifices 4613; then the outer commissure strut members (firstthe outer second commissure strut members 4619 y-1, then the outer firstcommissure strut member 4619 x-1, in variations in which the commissurestrut members comprise inner and outer components) may be placed ontothe alignment guides through orifices 4613; and then the innercommissure strut members (first the inner second commissure strut member4619 y-2; then the inner first commissure strut member 4619 x-2) may beplaced onto the alignment guides through orifices 4613. It should beappreciated that the strut members may also be placed onto the alignmentguides in an order from inner-most to outer-most: the inner commissurestrut members (first the inner first commissure strut member 4619 x-2,then inner second commissure strut members 4619 y-2) may be placed ontothe alignment guides through orifices 4613; then the outer commissurestrut members (first the outer first commissure strut member 4619 x-1,then the outer second commissure strut member 4619 y-1) may be placedonto the alignment guides through orifices 4613; then the inner layer oflongitudinal strut members (e.g. 4611-2, 4611-4) may then be placed ontothe alignment guides through orifices 4613; and then the outer layer oflongitudinal strut members (e.g. 4611-1, 4611-3) may first be placedonto the alignment guides through orifices 4613. It should beappreciated that these strut members may be placed onto the alignmentguides in other orders to the extent that the strut members are notplaced onto the same alignment guides.

In some variations, the alignment guides may comprise elongated pinsconfigured to fit through orifices of the strut members. The alignmentguides may be arranged in a desired orientation by placement on orthrough an alignment plate, which may comprise markings or openings toassist in alignment of the alignment guides. The alignment plate maycomprise an opening corresponding to the location of each orifice 4613of the strut members of support structure 4610. To use the alignmentplate to fabricate the support structure 4610, the alignment guides maybe placed through each opening that corresponds to the location of anarticulated Joint 4615 of support structure 4610. In other variations,the alignment plate may comprise an opening corresponding to thelocation of each articulated joint 4615. In such variations, to use thealignment plate to fabricate the support structure 4610, the alignmentguides may be placed through each opening of the alignment plate. Itshould be appreciated that the alignment guides throughout the methodsof fabrication described herein may have any suitable design for holdingthe strut members in place relative to each other. For example, thealignment guides may comprise rails that may fit around one or moreedges of the strut members, or the alignment guides may compriserecesses into which the strut members may fit.

The strut members may be held together via rivets. In some variations,the rivets may be placed onto the alignment guides before the strutmembers are placed onto the alignment guides. The eyelets or rivets maycomprise a larger portion and a smaller portion, where the largerportion of the eyelets or rivets (i.e., the flange) is larger in atleast one cross-sectional dimension than the smaller portion of theeyelets. The eyelet or rivet may be loaded onto the alignment guidessuch that the eyelet or rivet flange resides against to the alignmentplate. The dimensions of the flange of the eyelets or rivets may be suchthat it may not pass through the openings of the alignment plate. Thedimensions of the flange of the eyelets or rivets may also be such thatit may not pass through the orifices 4613 of the strut members of thesupport structure 4610, while the dimensions of the smaller portion ofthe eyelets or rivets may be such that it may pass through the orifices4613 of the strut members of the support structure 4610. Thus, when thestrut members are placed on the alignment guides, the narrower portionof the eyelets or rivets may pass through the orifices 4613, sandwichingthe flange between the alignment plate and the strut members. Thenarrower portion of the eyelets or rivets may have a height sufficientto pass fully through all of the elements layered into the alignmentguides during the fabrication process when the flange is sandwiched asdescribed, such that the end of the eyelet or rivet may be swaged.

After the strut members are layered on the alignment guides, the rivetsmay be swaged to secure the strut members together. The rivets and strutmembers may be removed from the alignment guides in order to swage therivets. In some variations, a hand tool may be used to swage the rivets.In other variations, the rivets may be swaged in an automated mannerusing XY frame machines. In some variations, the components may be heldin place during swaging by pressing the layered components between thealignment plate and a cover plate. The cover plate may comprise openingsthat may be configured to correspond to the location of the rivets, toallow access for swaging.

After the strut members are secured together via rivets, the flattenedchain may be shaped into the desired continuous support structure 4610,and the two ends of the flattened chain may be secured together viarivets. In some variations, the flattened chain may be shaped into thedesired shape by wrapping the flattened chain around a cylindrical mold.

The tissue valve 4621 may be mounted in a secure, sutureless mannerusing a similar method of fabrication. In one variation, the tissuevalve may be suturelessly attached to the support structure 4610 as partof the fabrication process described above using alignment guide bysandwiching the leaflets between the inner and outer longitudinal strutmembers and commissure strut members. In some variations, the leafletsmay comprise pre-cut openings configured to receive the alignment guides(e.g., elongated pins). In other variations, the alignment guides may beconfigured to pierce or cut the leaflets (e.g., by comprising asharpened or pointed end) in order to allow the leaflets to be placedover the alignment guides. The leaflets may be placed onto the alignmentguides between strut members, such that when the strut members are fixedtogether with rivets, as described above, the leaflets are as a resultfixed between the strut members. Coaptation struts may also be attachedusing the alignment guides. After the flattened chain is wrapped intothe continuous support structure 4610, the coaptation struts 4651 may berotated proximally from their fabrication position to their biasingposition, and the proximal ends may be attached to the commissure struts4651 to sandwich the leaflets of valve 4621 between the coaptationstruts 4651 and commissure strut members 4619.

It should be appreciated that while the fabrication method above isdescribed with respect to support structure 4610, a similar method maybe used for any number of support structure, valve, and skirt designs.to fabricate the other structures described here, which may or may nothave attached valves and/or skirts). For example, a similar method offabrication may be used to fabricate any of the support structuresdescribed herein (10, 10′, 2510, 2710, 3910, 3810, 4610), with orwithout attached skirts and/or valves.

In some variations, a skirt 4210 may be attached to the supportstructure 3810 using a fabrication method similar to that describedabove with respect to FIGS. 18A-18R. In one variation, depicted in FIGS.20A and 20B, the support structure 3810 with an attached skirt 4210 maybe fabricated by connecting strut members into a flattened chain bylayering the strut members and skirt and then securing them together. Asdescribed above with respect to support structure 4610, this may befacilitated using alignment guides. More specifically, to fabricate thestructure 3810 with skirt 4210, the strut members may be placed onto thealignment guides in an order from outer-most to inner-most. As shown inFIG. 20A, the strut members 3811 making up support structure 3810 mayfirst be placed onto the alignment guides through orifices 3813. Indoing so, the outer strut members 3811 (the set of three outer strutmembers 3811-2 (not shown) and three outer strut members 3811-4) mayfirst be placed onto the alignment guides through orifices 3813 at thelocations of the articulated joints 3815 (3815-1, 3815-5, 3815-11 and3815-3, 3815-7, 3715-9, respectively). The inner strut members 3811 (theset of three inner strut members 3811-1 and three inner strut members3811-3 (not shown)) may then be placed onto the alignment guides throughorifices 3813 at the locations of the articulated joints 3815 (3815-1,3815-3, 3815-9 and 3815-5, 3815-7, 3815-11, respectively). The skirtmaterial may then be placed above the strut members 3811. In somevariations, the skirt material may comprise openings configured toreceive the alignment guides through them. In other variations, thealignments may be configured to pierce or cut the skirt material (e.g.,by comprising a sharpened or pointed end) in order to allow thealignment guides to be placed through the skirt material. An outer layerof strut members 4311 may then be layered on top of the skirt material,as shown in FIG. 20A. In the variation shown in FIG. 20A, the strutmembers 4311 may comprise six struts 4311 having orifices 4313: threeinner strut members 4311-1 and three outer strut member 4311-2. Thethree outer strut members 4311-2 may first be placed onto the alignmentguides through orifices 4313; the three inner strut members 4311-1 maythen be placed onto the alignment guides through orifices 4313. Theplacement of the alignment guides through the inner and outer strutmembers 4311 may be such that each strut is placed over two alignmentguides; one at a location corresponding to articulated joint 4315-1spaced apart from its ends (which may or may not be a midpoint of thestrut member 4311), and one at a location corresponding to articulatedjoint 4315-2 at an end of the strut member (in the view shown in FIG.20A, the right-most end). Each of these alignment guides may go throughthe orifices 4313 of one inner strut member 4311-1 and one outer strutmember 4311-2.

It should also be appreciated that the strut members may also be placedonto the alignment guides in an order from inner-most to outermost. Inthis case, the strut members 4311 may first be placed onto the alignmentguides as described above, but with the three inner strut members 4311-1may first be placed onto the alignment guides, and the three outer strutmembers 4311-2 then be placed onto the alignments guides. The skirtmaterial may then be placed above the strut members 4311 and onto thealignment guides, in a manner similar to that described above. The strutmembers 3811 of support structure 3810 may then be placed onto thealignment guides, with inner strut members 3811-1, 3811-3 being placedfirst onto the alignment guides, and then outer strut members 3811-2,3811-2 being placed onto the alignment guides.

In some variations, the alignment guides may comprise elongated pinsconfigured to fit through the orifices of the strut members. Thealignment guides may be arranged in a desired orientation by placementon or through an alignment plate, which may comprise markings oropenings to assist in alignment of the alignment guides. The alignmentplate may comprise an opening corresponding to the location of eachorifice 3813 and 4313 of the strut members 3811 and 4311, and thealignment guides may be placed through each opening corresponding to thelocation of an articulated joint 3815 or 4315. In other variations, thealignment plate may comprise an opening 3620 corresponding to thelocation of each desired articulated joint 3815 and 4315. In suchvariations, to use the alignment plate, the alignment guides may beplaced through each opening of the alignment plate. It should berecognized that the alignment guides placed through orifices 4313 of thestrut members 4311 need not be the same alignment guides placed throughorifices 3813 of strut members 3811 of support structure 3810.

It should also be appreciated that the strut members 4311 may have othernumbers and configurations. In some variations, the strut members 4311may have the same number and configuration as strut members 3811 makingup support structure 3810. Furthermore, a similar method of fabricationmay be used for attaching a skirt to other support structures ofcombination structures. In general, the skirt may be attached to asupport structure by sandwiching the skirt between the strut members oftwo support structures. These two support structures may be the same, orthe two support structures may be different (as in the example abovewith strut members 3811 and 4311). FIG. 20B illustrates another examplein which the skirt 4320 is sandwiched between two sets of strut members3911 both configured to make up a support structure 3910 when connectedinto a continuous support structure. Similarly to described above withrespect to FIG. 20A, the strut members may be connected into a flattenedchain by layering the strut members and the skirt and then securing themtogether, which may be facilitated using alignment guides. Morespecifically, to fabricate the structure 3910 with skirt 4220, the strutmembers may be placed onto the alignment guides in an order fromouter-most to inner-most. The strut members 3911 making up supportstructure 3910 may first be placed onto the alignment guides throughorifices 3913. In doing so, the outer strut members 3911 (the set ofthree outer strut members 3911-2 and three outer strut members 3911-4)may first be placed onto the alignment guides through orifices 3913 atthe locations of the articulated joints 3915 (3915-1, 3915-5, 3915-11,3915-15 and 3915-3, 3915-7, 3915-9, 3915-13 respectively). The innerstrut members 3911 (the set of three inner strut members 3911-1 andthree inner strut members 3911-3) may then be placed onto the alignmentguides through orifices 3913 at the locations of the articulated joints3915 (3915-1, 3915-3, 3915-9, 2915-15 and 3915-5, 3915-7, 3915-11,3915-13 respectively). The skirt material may then be placed above thestrut members 3811. In some variations, the skirt material may compriseopenings configured to receive the alignment guides through them. Inother variations, the alignments may be configured to pierce or cut theskirt material (e.g., by comprising a sharpened or pointed end) in orderto allow the alignment guides to be placed through the skirt material.An outer layer of strut members 3911 may then be layered on top of theskirt material, as shown in FIG. 20B. The inner strut members 3911 (theset of three inner strut members 3911-1 and three inner strut members3911-3) may first be placed onto the alignment guides through orifices3913 at the locations of the articulated joints 3915 (3915-1, 3915-3,3915-9, 2915-15 and 3915-5, 3915-7, 3915-11, 3915-13 respectively). Theouter strut members 3911 (the set of three outer strut members 3911-2and three outer strut members 3911-4) may then be placed onto thealignment guides through orifices 3913 at the locations of thearticulated joints 3915 (3915-1, 3915-5, 3915-11, 3915-15 and 3915-3,3915-7, 3915-9, 3915-13 respectively).

In some variations, the alignment guides may comprise elongated pinsconfigured to fit through the orifices of the strut members. Thealignment guides may be arranged in a desired orientation by placementon or through an alignment plate. An example of an alignment plate 4410is shown in FIG. 18A, which may comprise markings 4440 and openings 4420to assist in alignment of the alignment guides. The alignment plate 4410may comprise an opening 4420 corresponding to the location of eachorifice 3913 of the strut members 3911, and the alignment guides may beplaced through each opening corresponding to the location of anarticulated joint 3915. In other variations, the alignment plate maycomprise an opening corresponding to the location of each desiredarticulated joint 3815 and 4315. In such variations, to use thealignment plate, the alignment guides may be placed through each openingof the alignment plate. It should be recognized that the alignmentguides placed through orifices 4313 of the strut members 4311 need notbe the same alignment guides placed through orifices 3813 of strutmembers 3811 of support structure 3810.

The strut members discussed with respect to FIGS. 20A and 20B may beheld together via rivets. In some variations, the rivets may be placedonto the alignment guides before the strut members are placed onto thealignment guides.

After the strut members are placed onto the alignment guides, the rivetsmay be swaged to secure the strut members together. In some variations,a hand tool may be used to swage the rivets. In other variations, therivets may be swaged in an automated manner using XY frame machines. Thealignment guides may then be removed from the orifices. In somevariations, the components may be held in place during swaging bypressing the layered components between the alignment plate and a coverplate. The cover plate may comprise openings that may be configured tocorrespond to the location of the rivets, to allow access for swaging.

After the strut members are secured together via rivets, the flattenedchain may be shaped into a continuous support structure, and the twoends of the flattened chain may be secured together via rivets. In somevariations, the flattened chain may be shaped into the desired shape bywrapping the flattened chain around a cylindrical mold.

FIGS. 23A to 23Q schematically depicts another assembly process for anarticulated stent structure. In this particular assembly, severaloptional features of the articulated stent structure are also included,but in other variations, one or more, or all of these optional featuresmay be excluded. The assembly process utilizes an assembly systemcomprising a backing plate or support 5002 and a cover plate or support5004, depicted in FIGS. 21A and 21B, respectively, along with alignmentpins (for clarity, not shown in the pin openings 5006 of the backingplate 5002), which are used to facilitate alignment of the various stentcomponents during the manufacturing process. In this particularembodiment, the stent structure comprises an optional sealing material5008, shown in FIG. 22A, and optional valve leaflets 5010, shown in FIG.22B. As shown in FIG. 21A, optional indicia or template markings 5020may be provided on the backing plate 5002 to facilitate proper placementof the struts, and in some variations the markings may have a shape likethe struts to be placed into the backing plate 5002.

In this exemplary embodiment, the backing plate 5002 is placed onto ajig or other structure configured to removably retain the backing plate5002, but in other embodiments the backing plate may be integrallyformed with a jig or other assembly structure. Pins are then placedthrough the pin openings 5006 of the backing plate 5002.

Referring to FIG. 23B, a seal material 5008 is placed onto the backingplate 5002 through the pins. Optionally, placement of the seal material5008 may be optionally performed using a support structure 5012 coupledto the top surface of the seal material, as shown in FIG. 23A. Thesupport structure 5010 may comprise preformed openings 5014 for thepins, which may facilitate piercing of the seal material 5008 by thepins, in embodiments where the seal material 5008 does not havepreformed pin openings. After placement of the seal material 5008, thesupport structure 5012 may be removed, leaving behind the seal material5008, as shown in FIG. 23B.

Referring to FIG. 23C, eyelets 5016 are then place onto each pin, thehead or wider portion facing downward, against the seal material 5008.These may be performed by machine, or may be performed by hand. Forcepsor other hand tools may be used for eyelet placement. The eyelets 5016may be placed in any order, but in some variations, may be placed in anordered fashion from a first side to a second side, such as fromposition 1 to 41, as shown in FIG. 23C. The number of eyelets in any oneembodiment may be different, but in some variations, the number ofeyelets may be in the range of 35 to 45, or 30 to 50, or 20 to 40, or 15to 50, or 20 to 60, for example. The first side to the second side maybe from left-to-right, right-to-left, top-to-bottom or bottom-to-top,for example.

FIG. 23D depicts the placement of the lower struts. In this embodiment,the lower struts 5018 at positions 1 and 2 are placed first, followed bythe lower struts 5020. This arrangement achieves an overlap of the outerlower struts 5018 with inner lower struts 5020, as well as an inner andouter strut configuration, which may achieve a smaller collapsed profileand ease of expansion and reduction of the stent structure. In theexemplary process depicted in FIGS. 23A to 23Q, strut positioning ontothe backing plate is performed in a left to right manner, but in otherexamples may be performed in a right to left manner, or some othermanner. A consistent assembly direction may or may not reduce assemblyerrors during the manufacturing process.

In FIG. 23E, the end struts 5022 are placed onto backing plate 5002. Insome variations, one or more of the strut positions may comprise twobars at the same location, whether for reinforcement or other purpose.For example, in one further embodiment, the strut location at position 1may comprise two struts 5018 at the same location, while the strutlocation at position 2 may comprise a single strut 5018.

In FIG. 23F, the first set of upper struts 5024 are then placed onto thebacking plate 5002, starting from position 1 to 2 to 3. In thisparticular example, optional commissure struts are also provided, suchthat the upper struts 5022 comprise an enlarged end 5026 which should beoriented superiorly during placement. In other embodiments, however,each of the struts may or may not involve a particular orientation.After placement of upper struts 5024, one of the upper struts 5024overlaps with one of the end struts, and each of the upper struts 5024overlaps with one or two lower struts, but not with each other.

In FIG. 23G, the second set of upper struts 5028 are then placed,starting from position 1 to 2 to 3, from left to right, with theenlarged end 5030 oriented superiorly during placement. Each of thesecond set of upper struts 5030 overlap one or more lower struts, butnot with each other.

In FIG. 23H, the first side or set of commissure struts 5032 are placedonto the backing plate 5002. In this particular embodiment, the firstset of commissure struts 5032 are the right side struts at thecommissures, as viewed during assembly, and may be assembled in orderfrom positions 1 to 2 to 3, from left to right. Each of the first set ofcommissure struts overlaps with an upper strut at this juncture in theassembly process.

In FIG. 23I, the second side or set of commissure struts 5034 are placedonto the backing plate 5002. In this particular embodiment, the secondset of commissure struts 5034 are the left side struts at thecommissures, as viewed during assembly, and may be assembled in orderfrom positions 1 to 2 to 3, from left to right. Each of the second setof commissure struts 5034 overlaps with a corresponding commissure strutfrom the first set, and also an upper strut.

In an variation of the assembly process, instead of each commissurecomprising a two part stent, a single piece wishbone or inverted U-shapecommissure strut may be used instead, as in some designs, no movementbetween the two attached commissure struts occurs, or is otherwiserequired.

With the struts in place on the backing plate, in embodiments optionallyincluding the seal material, the seal material 5008 may be optionallymanipulated so that the seal material 5008 may be folded back or tuckedin between struts, without using sutures. Referring to FIG. 23J, foldingpins 5036 are initially positioned with their heads 5042 in the superiorposition pushed against the seal material 5008 close to the upper edge5038 of the seal material 5008, between the eyelets 5040 the upperstruts 5022. The pins 5036 are pushed just enough to contact the struts5024. The pins 5036 are then pivoted or levered in an inferior directionuntil the heads 5042 of the pins 5036 are almost contacting the backingplate 5002. Then pins 5036 are then pushed under struts 5024 and throughthe seal material 5008 so that the strut 5024 is generally located aboutthe middle of the pin 5036, as shown in FIG. 23J. In this particularexample, four pins 5036 are used along on of the struts 5024, but inother embodiments one, two, three, five, six, seven, eight, nine, or tenor more pins may be used long a strut. FIG. 23K depicts all the pins5036 after pivoting or levering along all of the upper struts 5024 and5028.

In FIG. 23L, three optional valve leaflets 5010 are then placed on thebacking plate 5002, from positions 1 to 2 to 3, left to right, alignedwith the pins corresponding to the commissure struts 5032, 5034 andupper struts 5024 and 5028, shown in earlier figures but covered up bythe leaflets in FIG. 23L. Typically, the leaflet material is maintainedin a wet state, and may be wetted during assembly to resist or avoiddesiccation.

In FIG. 23M, a third set of commissure struts or posts 5046 are thenpositioned onto the backing plate 5002 using pins, onto the valveleaflets 5010, from positions 1 to 2 to 3, left to right. In FIG. 23N,this is followed by a fourth set of commissure struts or posts 5048 thatare placed onto the backing plate 5002 using pins onto the valveleaflets 5010, from positions 1 to 2 to 3, left to right. In conjunctionwith the first and second sets of commissure struts 5032, 5034, aportion of each valve leaflet 5042 is sandwiched between, or otherwisesecured tot eh commissure struts 5032, 5034, 5046 and 5048.

In FIG. 230, a first set of curved struts 5050 are then positioned ontothe backing plate 5002 against the leaflets 5010, from positions 1 to 3to 4, left to right. After each strut placement, the folding pins 5036are removed, prior to the placement of the next curved strut 5050, asindicated by removal steps 2 to 4 to 6. This is followed by theplacement of another set of curved struts 5052 onto the leaflets 5010and the backing plate 5002, from positions 1 to 3 to 4, left to right,as shown in FIG. 23P, which also involve the removal of folding pins5036 after each strut placement. These curved struts 5050, 5052 arepushed sufficiently such that the struts 5050, 5052 may contact theeyelets (not shown in FIG. 230 or 23P).

After the eyelets, struts, sealing material and valve leaflets have beenloaded onto the backing plate 5002, the cover plate 5004 or clampingplate is then placed on top of all the components, sandwiching thecomponents between the backing plate 5002 and the cover plate 5004, asshown in FIG. 23Q. Retaining clips 5056 or clamps, may be attached toattachment sites 5054 on the backing plate, to keep the components andthe cover plate 5004 together, so that the backing plate 5002,components and cover plate 5004 may be optionally removed as a singlecomposite structure to a swaging machine. The clips 5056 may berotatable to facilitate clamping or removal of the cover plate 5004 fromthe backing plate 5002. The backing plate 5002 and the cover plate 5004may also optionally comprise alignment openings or structures which mayform a complementary interfit between the two plates 5002, 5004 orpermit a post or pin to be used to maintain or facilitate platealignment. In the example depicted in FIGS. 21A and 21B, the backingplate comprises cover plate opening 5058 which are configured to alignwith backing plate openings 5060 on the cover plate 5004 via post orpins inserted therethrough.

As shown in FIG. 21B, in addition to the plurality of alignment pinopenings 5062 configured to receive pins projecting through the backingplate and through the cover plate 5004, the cover plate may optionallycomprise leaflet openings 5064. In some variations, the leaflet openings5064 permit viewing of the leaflet to confirm the positioning of theleaflets during clamping, or to confirm that damage to the leaflets hasnot occurring during clamping or swaging.

In other examples, however, the swaging tool may be integrated into ajig, such that a cover plate is not needed and swaging may be directlyperformed on the components, without a cover plate. Each of the eyeletsare then swaged, either with the pins in place or with the pins removedbefore swaging. The eyelet swaging may be performed in a single step foreach eyelet, or may comprise two or more steps for each eyelet, wherethe swaging tool acts only on one side of the eyelet at a time. Theeyelets may be swaged serially or simultaneously in parallel.

In some variations, additional sutures or eyelets may be placed at thecommissure struts, upper struts or lower struts, to further attacheither the valve leaflets or the sealing material to the assembly. Forexample, an additional eyelet may be swaged at each commissure edge ofeach valve leaflet to further attach the leaflets to the commissurestruts.

After swaging, the assembled layered valve assembly is removed from thebacking plate, and the side ends of the layered valve assembly areattached to circularize the layered valve assembly into a tubular orring-like structure. If a shim was used, the shim may be removed fromthe assembly before circularization is performed. Because the shim waslocated between the seal material and the eyelets, the shim may beremoved once the pins are removed.

In some further variations, the sealing material may be pre-attached tothe support structure, by a mechanical or an adhesive mechanism. Thesupport layer may comprise a metal or hard plastic. As noted above, inuse, the sealing material may be pierced by the alignment pins duringassembly, but in other variations, the sealing material may comprisepre-formed openings configured to receive the alignment pins. Likewise,the valve leaflets 5010 depicted in FIG. 22B may optionally comprisepre-formed pin openings 5044.

In some further embodiments, a protective insert or shim 5066, depictedin FIG. 21C, may be optionally placed on top of the lower portion of thesealing material 5008, after the sealing material 5008 is placed ontothe backing plate 5002 and before any struts are placed. In somevariations, the shim 5066 may aid in protecting the sealing material5008 during the assembly and or swaging procedure, and may be removedprior to tubularization of the device. The shim 5066 may comprisetriangular base regions 5068 and elongate commissure regions 5070. Theshim 5066 may comprise pin apertures 5072 to facilitate or maintaindesired positioning of the shim 5066 on the backing plate 5002 via thealignment pins. In this particular embodiment, the apertures 5072 of theshim 5088 correspond to the openings 5006 on the backing plate 5002 forthe upper struts of the device, but in other embodiments, the shimapertures may correspond to other openings 5006 on the backing plate, orother alignment openings independent of the strut alignment openings.The shim may comprise a metal or plastic material, or other material.

Either prior, during or after tubularization, the seal material 5008 isfurther attached to stent assembly by wrapping its upper tabs 5078 andits lower tabs 5080 around the commissure struts. The wrapping may gofrom the outer surface of the commissure struts, to the inner surface,and then back to the outer surface, depending upon the length of thetabs. In some embodiments, the sealing material provides sufficientcoverage such that there is no exposed stent on the outer perimeter ofthe stent assembly. The seal material 5008 may then be secured to thecommissure struts using sutures and the eyelets of the commissurestruts, or by adhesive or tissue welding, or other known attachmentmodalities. In other variations, a single tab may be provided to eachside of the commissure extension 5076 of the sealing material, or thesingle tab may be provided to just one side of the commissure extension,like a flag and pole configuration. In some variations, the tabs maycomprise a trapezoidal or half-trapezoidal shape, with a wider base anda narrower distal end.

In some variations, the base 5074 of the sealing material 5008 isattached to the lower struts of the valve or stent assembly, but inother variations, the base 5074 remains unattached, even where thecommissure extensions are attached to the commissure struts. In somevariations, the base 5074 are left unattached to permit expansion of thestent assembly, without the base 5074 constraining expansion due toattachment to the stent assembly. In some further variations, the valveassembly is then placed and secured to a second stent assembly, e.g. oneconfigured for aortic or mitral valve placement, and then the base 5074of the sealing material 5008 is then attached to the second stentassembly. Examples of combination or composite valve structures aredescribed in U.S. Pub. 2014/0277563, which is hereby incorporated byreference in its entirety.

Particular embodiments of the invention offer distinct advantages overthe prior art, including in their structure and applications. Whilecertain advantages are summarized below, the summary is not necessarilya complete list as there may be additional advantages.

The device may allow the user to advert the serious complications thatcan occur during percutaneous heart valve implantation. Because thedevice may be configured to be retrievable and re-positionable duringimplantation into the body, the surgeon may be able to avoid seriouscomplications due to valve mal-positioning or migration duringimplantation. Examples of these complications include occlusion of thecoronary arteries, massive paravalvular leakage, or arrhythmias.

The device may also decrease vascular access complications because ofthe device's narrow insertion profile. The device's profile may be low,in part, due to its unique geometry, which may allow neighboring strutsin the stent to overlap during stent compression. The device's lowprofile may be further augmented by eliminating the necessity for aballoon or a sheath. In some embodiments, however, the device may beplaced within a sheath during insertion. The device's narrow profileoffers the advantage of widening the vascular access route options inpatients. For instance, the device may enable the delivery of theprosthetic valve through an artery in the leg in a patient whom wouldhave previously been committed to a more invasive approach through thechest wall. The device may therefore decrease complications associatedwith the use of large profile devices in patients with poor vascularaccess.

The tissue valve embodiments can offer improved durability by allowingfor attachment of the leaflets to flexible commissural posts. Theflexible posts may allow dissipation of the stress and strain imposed onthe leaflet by the cardiac cycle. The use of multi-ply struts may enablethe leaflets to be sandwiched in between the struts, which mayre-enforce the leaflet attachments and prevents tearing of sutures andprovide a significantly simplified approach for leaflet attachment. Thevalve may further assume a desirable leaflet morphology, which mayfurther reduce the stress and strain on leaflets. Namely, the angledleaflet attachment to the stent may be similar to the native humanaortic valve's inter-leaflet trigone pattern. These properties maysignificantly improve the longevity of percutaneous heart valvereplacement therapies. In addition, in comparison to Nitinol frames, thesupport structure may have more forceful expansion and higher hoopstrength, and may be more fatigue resistant while collapsing moreeasily. Moreover, it may not require cooling or warning to cause shapechanges.

The device could reduce or eliminate arrhythmia complications due to theincremental expansion or compression of the stent. The stent can employa screw mechanism for deployment, which enables the stent to self-lockor un-lock at all radii. This may enable more controlled deployment andthe potential for individualizing the expansion or compression of thedevice in each patient. Because the expansion or compression of thedevice may be configured to be reversible at any stage during theprocedure, the surgeon may be able to easily reverse the expansion ofthe device to relieve an arrhythmia. In addition, if an arrhythmia isdetected during implantation, the device may be able to be repositionedto further eliminate the problem.

The device may reduce or eliminate paravalvular leak due to the device'sability to be accurately positioned, and re-positioned, if necessary.That may considerably decrease the occurrence and severity ofparavalvular leaks. The device may also reduce or eliminate paravalvularleak due to the ability to retain a dynamic seal.

The device may eliminate balloon-related complications. The screwmechanism of deployment exploits the mechanical advantage of a screw.This may provide for forceful dilation of the stent. The lever armscreated by the pivoting of the struts in the scissor linkage of thestent may transmit a further expansion force to the stent. The stent maybe expanded without the need for a balloon. In addition, the device mayhave the ability to be forcefully dilated, which may reduce or eliminatethe need for pre- or post-ballooning during the implantation procedurein patients.

The device may have more predictable and precise positioning in the bodybecause the difference between the height of the stent in the compressedand expanded position may be small. This “reduced foreshortening” mayhelp the surgeon to position the device in the desirable location in thebody. The ability to re-position the device in the body may furtherconfer the ability to precisely position the device in each individual.

In addition to the mechanical advantages, the device may enable a widerpopulation of patients to be treated by a less invasive means for valvereplacement. For example, the device may enable patients withco-morbidities, who are not candidates for open chest surgical valvereplacement, to be offered a treatment option. The device's ability toassume a narrow profile may also enable patients who were previouslydenied treatment due to poor vascular access (e.g. tortuous, calcified,or small arteries), to be offered a treatment option. The durability ofthe valve may expand the use of less-invasive procedures to thepopulation of otherwise healthy patients, who would otherwise becandidates for open chest surgical valve replacement. The device'sability to be forcefully expanded, or assume hourglass, or conicalshapes, potentially expands the device application to the treatment ofpatients diagnosed with aortic insufficiency, as well as aorticstenosis.

The device can also provide a less invasive treatment to patients withdegenerative prosthesis from a prior implant, by providing for a“valve-in-valve” procedure. The device could be accurately positionedinside the failing valve, without removing the patient's degenerativeprosthesis. It could help the patient by providing a functional valvereplacement, without a “re-do” operation and its associated risks.

While this invention has been particularly shown and described withreferences to particular embodiments, it will be understood by thoseskilled in the art that various changes in form and details may be madeto the embodiments without departing from the scope of the inventionencompassed by the appended claims. For the methods disclosed herein,the steps need not be performed sequentially. Each of the featuresdepicted in each embodiment herein in may be adapted for use in otherembodiments herein.

I claim:
 1. A prosthetic heart valve, comprising: a support structurehaving a first end, a second end, a central longitudinal axis extendingfrom the first end to the second end, and a plurality of struts and aplurality of rivets, wherein each of the struts has a first end portion,a second end portion, and a third portion extending from the first endportion to the second end portion, wherein each of the struts hasopenings in the first end portion, the second end portion, and the thirdportion, wherein each of the struts has a length dimension, a widthdimension, and a thickness dimension, wherein the length dimensionextends from the first end portion to the second end portion and isgreater than the width dimension and the thickness dimension, whereinthe width dimension is a cross-sectional dimension perpendicular to thelength dimension and the thickness dimension and is greater than thethickness dimension, wherein the thickness dimension is a radialdimension relative to the central longitudinal axis, wherein each of thestruts comprises a first width at first locations circumscribing theopenings and a second width at second locations extending from one ofthe first locations to another one of the first locations, wherein thesecond width is less than the first width and is uniform throughout,wherein the rivets have first portions, second portions, and thirdportions, wherein the first portions are disposed between the secondportions and the third portions, wherein the first portions of therivets comprise a third width and extend through the openings of thestruts, wherein the second portions of the rivets comprise a fourthwidth disposed on outer-facing surfaces of the struts, wherein thefourth width is greater than the second width and the third width,wherein the third portions of the rivets comprise a fifth width disposedon inner-facing surfaces of the struts, wherein the fifth width is lessthan the first width and greater than the third width, and wherein thestruts are pivotable about the rivets to radially expand and compressthe support structure; an actuator member coupled to the struts of thesupport structure and configured to selectively actuate expansion andcompression of the support structure; and a plurality of leafletscoupled to the support structure and configured to allow unidirectionalblood flow through the prosthetic heart valve.
 2. The prosthetic heartvalve of claim 1, wherein the openings formed in the struts includethree or more openings formed in each of the struts, and each of therivets extends through the openings of two adjacent struts.
 3. Theprosthetic heart valve of claim 1, wherein the first portions of therivets are shaft portions sized such that the shaft portions extendthrough the openings of the struts, and wherein the second portions ofthe rivets are flange portions extending radially outwardly from endportions of the shaft portions.
 4. The prosthetic heart valve of claim1, wherein the actuator member is configured to reversibly andincrementally adjust the support structure between an expandedconfiguration and a compressed configuration.
 5. The prosthetic heartvalve of claim 1, further comprising a skirt, wherein the skirt iscoupled to the struts by sandwiching the skirt between the struts. 6.The prosthetic heart valve of claim 5, wherein at least one strut isdisposed on a first side of the skirt, and at least other strut isdisposed on a second side of the skirt.
 7. The prosthetic heart valve ofclaim 5, wherein one or more of the rivets extend through the skirt. 8.The prosthetic heart valve of claim 1, wherein the support structurefurther includes a first mount and a second mount spaced from the firstmount, wherein the first and second mounts are coupled to the struts,and wherein the actuator member is rotatably coupled to the first andsecond mounts.
 9. The prosthetic heart valve of claim 8, whereinactuator member is configured such that rotating the actuator member ina first direction relative to the first and second mounts expands thesupport structure and such that rotating the actuator member in a seconddirection relative to the first and second mounts compresses the supportstructure.
 10. A prosthetic heart valve, comprising: a support structurehaving a first end, a second end, a central longitudinal axis extendingfrom the first end to the second end, a plurality of inner struts, aplurality of outer struts, and a plurality of rivets, wherein each ofthe inner struts and each of the outer struts has a plurality ofopenings formed therein, wherein each of the inner struts and each ofthe outer struts has a length dimension, a width dimension, and athickness dimension, wherein the thickness dimension extends radiallyrelative to the central longitudinal axis and is less than the widthdimension and the length dimension, wherein the width dimension is across-sectional dimension perpendicular to the length dimension and thethickness dimension and is less than the length dimension, wherein eachof the inner struts and each of the outer struts comprises a pluralityof first segments circumscribing the openings and having a first widthand a plurality of second segments extending from and interconnectingadjacent first segments and having a second width, wherein the secondwidth is less than the first width and is constant along the entirelength of the second segment, wherein the rivets have first portionswith a third width second portions with a fourth width, and thirdportions with a fifth width, wherein the fourth width is greater thanthe third width and the second width, wherein the first portions extendbetween the second portions and the third portions through the openingsof the inner struts and the outer struts, wherein the second portionsare disposed on inner sides of the inner struts, wherein the thirdportions are disposed on outer sides of the outer struts, wherein thefifth width is less than the first width and greater than the thirdwidth, and wherein the inner struts and the outer struts are pivotablerelative to each other about the rivets to radially expand and compressthe support structure; an actuator member coupled to the supportstructure and configured to selectively actuate expansion andcompression of the support structure; a plurality of leaflets coupled tothe support structure and configured to allow unidirectional blood flowthrough the prosthetic heart valve; and a skirt comprising an innersurface and an outer surface, wherein the skirt is sandwiched betweeneach of the inner struts and the outer struts of the support structure,wherein the inner struts circumscribe the inner surface of the skirt,and wherein the outer struts circumscribe the outer surface of theskirt.
 11. The prosthetic heart valve of claim 10, wherein the skirtcomprises one or more openings, and wherein one or more of the rivetsextend through the one or more openings of the skirt.
 12. The prostheticheart valve of claim 10, wherein the openings of the inner struts andthe outer struts include three or more openings formed in each of theinner struts and the outer struts, and wherein each of the rivetsextends through the openings of two adjacent struts.
 13. The prostheticheart valve of claim 10, wherein the first portions of the rivets areshaft portions, and wherein the second portions of the rivets are flangeportions extending radially outwardly from end portions of the shaftportions.
 14. A prosthetic heart valve, comprising: a support structurehaving a first end, a second end, a central longitudinal axis extendingfrom the first end to the second end, a plurality of inner struts, aplurality of outer struts, and a plurality of mounts coupled to theinner struts or the outer struts, wherein each of the inner struts andthe outer struts includes an inflow end portion, an outflow end portion,an intermediate portion disposed between the inflow end portion and theoutflow end portion, a first opening formed in the inflow end portion, asecond opening formed in the outflow end portion, and an intermediateopening formed in the intermediate portion, wherein each of the innerstruts and each of the outer struts has a length dimension, a widthdimension, and a thickness dimension, wherein the length dimension isgreater than the width dimension and the thickness dimension, whereinthe width dimension is a cross-sectional dimension perpendicular to thelength dimension and the thickness dimension and is greater than thethickness dimension, wherein the thickness dimension is a radialdimension relative to the central longitudinal axis, wherein each of theinner struts and the outer struts comprises a first width at locationscircumscribing the first opening, the second opening, and theintermediate opening and comprises a second width at a firstintermediate location extending between the locations circumscribing thefirst opening and the intermediate opening and at a second intermediatelocation extending between the locations circumscribing the secondopening and the intermediate opening, wherein the second width is lessthan the first width and is uniform, wherein adjacent pairs of inner andouter struts are coupled together by a plurality of rivets, wherein eachrivet has a shaft portion, a first flange portion, and a second flangeportion, wherein the first flange portion extends from the shaft portionaway from the central longitudinal axis, wherein the second flangeportion extends from the shaft portions towards the central longitudinalaxis and is spaced apart from the first flange portion, wherein theshaft portion has a third width and extends through the openings of theinner struts and the outer struts, wherein the first flange portion hasa fourth width, wherein the fourth width is greater than the secondwidth and the third width, wherein the second flange portion has a fifthwidth that is less than the first width and greater than the thirdwidth, and wherein the inner struts and the outer struts are pivotableabout the rivets to radially expand and compress the support structure;an actuator member coupled to the mounts of the support structure andconfigured to selectively actuate expansion and compression of thesupport structure, wherein rotating the actuator member in a firstdirection relative to the mounts expands the support structure, andwherein rotating the actuator member in a second direction relative tothe mounts compresses the support structure; a plurality of leafletscoupled to the support structure and configured to allow unidirectionalblood flow through the prosthetic heart valve; and a skirt materialcoupled to the support structure, wherein all of the inner struts aredisposed on a first side of the skirt material, and wherein all of theouter struts are disposed on a second side of the skirt material. 15.The prosthetic heart valve of claim 14, wherein one or more of therivets extend through the skirt material.
 16. The prosthetic heart valveof claim 14, wherein the actuator member is configured to reversibly andincrementally adjust the support structure between an expandedconfiguration and a compressed configuration.
 17. The prosthetic heartvalve of claim 14, wherein the rivets are hollow.
 18. The prostheticheart valve of claim 17, wherein the first flange portion or the secondflange portion of each rivet is formed by swaging.
 19. The prostheticheart valve of claim 14, wherein the skirt material comprises one ormore openings, and wherein one or more of the rivets extend through theone or more openings of the skirt material.